Generic placeholder image

Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Research Article

Robust U-HPLC Method Development of Desonide and its Application to In Vitro Release Testing (IVRT) of Topical Cream Products

Author(s): Seelam Jayadev and Ismail Yusuff*

Volume 20, Issue 5, 2024

Published on: 08 July, 2024

Page: [327 - 344] Pages: 18

DOI: 10.2174/0115734129298659240606103013

Price: $65

conference banner
Abstract

Background: The study focuses on establishing In Vitro Release Testing (IVRT) parameters for Desonide cream, following the guidelines of the Topical Classification System (TCS), to assess the bioequivalence between the Reference Listed Drug (RLD) and test.

Aims: This study aimed to develop a reliable IVRT method using Franz diffusion cells. An environmentally friendly U-HPLC method was created to analyze Desonide in the samples.

Objectives: To evaluate the drug release in Desonide products in accordance with SUPAC guidance, quantify the drug concentration using an analytical method, as per bioanalytical method validation guidelines, and ensure that the results meet the acceptance criteria. Linearity was established from 0.50 μg/mL to 40 μg/mL with acceptable regression values. Precision was confirmed three times, with an average % RSD of below 15% for 3 sets of 6QC level sample preparations. Stability tests demonstrated Desonide stability in receptor fluid (LLOQ and ULOQ) for 72 hours at 2-8°C and 25°C. Autosampler stability at LQC and HQC levels was proven at 25°C for 72 hours. Additionally, the stock solution remained stable at both 25°C and 2-8°C for 72 hours.

Methods: The study involved evaluating the dosing regimen, release medium, and membrane while optimizing the U-HPLC method based on three variables including column temperature, mobile phase composition, and flow rate. After experimentation, it was determined that Nylon membrane and 0.9% NaCl: Methanol release media (70:30 v/v) with 1000 mg dose were used to maximize the release profile of desonide.

Results: The created explanatory strategy is precise, delicate, and exact for measuring Desonide, with satisfactory Limits of Location LOD and Lower Limits of Measurement LLOQ measured at 0.15 and 0.50 ng /mL, respectively. The Regression coefficient r2 was identified to be 0.9996. The degree of Desonide measurement lessening was considered palatable, basically since the recuperation was underneath 30.00, additionally due to the favourable linear relationship watched within the Desonide discharge rates amid the IVRT study.

Conclusion: All three generic products analyzed were found to be equivalent to the RLD, meeting for "sameness" outlined in the FDA's SUPAC-SS guidance. A novel U-HPLC method was developed for Desonide, covering the range from 0.5 to 40 μg/ml, with intra and inter-day variability below 2% RSD. Additional characterizations were established, and the stability of Desonide was successfully determined.

Keywords: Desonide, ultra high-performance liquid chromatography (U-HPLC), vertical diffusion cell, food and drug administration, IVRT, united states pharmacopoeia, topical formulation, cream.

Graphical Abstract
[1]
Shah, V.P. Progress in methodologies for evaluating bioequivalence of topical formulations. Am. J. Clin. Dermatol., 2001, 2(5), 275-280.
[http://dx.doi.org/10.2165/00128071-200102050-00001] [PMID: 11721645]
[2]
Olejnik, A.; Goscianska, J.; Nowak, I. Active compounds release from semisolid dosage forms. J. Pharm. Sci., 2012, 101(11), 4032-4045.
[http://dx.doi.org/10.1002/jps.23289] [PMID: 22886492]
[3]
Yacobi, A.; Shah, V.P.; Bashaw, E.D.; Benfeldt, E.; Davit, B.; Ganes, D.; Ghosh, T.; Kanfer, I.; Kasting, G.B.; Katz, L.; Lionberger, R.; Lu, G.W.; Maibach, H.I.; Pershing, L.K.; Rackley, R.J.; Raw, A.; Shukla, C.G.; Thakker, K.; Wagner, N.; Zovko, E.; Lane, M.E. Current challenges in bioequivalence, quality, and novel assessment technologies for topical products. Pharm. Res., 2014, 31(4), 837-846.
[http://dx.doi.org/10.1007/s11095-013-1259-1] [PMID: 24395404]
[4]
Klein, R.R.; Heckart, J.L.; Thakker, K.D. In vitro release testing methodology and variability with the vertical diffusion cell (VDC). Dissolut. Technol., 2018, 25(3), 52-61.
[http://dx.doi.org/10.14227/DT250318P52]
[5]
Thakker, K.D.; Chern, W.H. Development and validation of in vitro release tests for semisolid dosage forms—Case study. Dissolut. Technol., 2003, 10(2), 10-15.
[http://dx.doi.org/10.14227/DT100203P10]
[6]
Tiffner, K.I.; Kanfer, I.; Augustin, T.; Raml, R.; Raney, S.G.; Sinner, F. A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5%. Int. J. Pharm., 2018, 535(1-2), 217-227.
[http://dx.doi.org/10.1016/j.ijpharm.2017.09.049] [PMID: 28935255]
[7]
Lusina Kregar, M.; Dürrigl, M.; Rožman, A.; Jelčić, Ž.; Cetina-Čižmek, B.; Filipović-Grčić, J. Development and validation of an in vitro release method for topical particulate delivery systems. Int. J. Pharm., 2015, 485(1-2), 202-214.
[http://dx.doi.org/10.1016/j.ijpharm.2015.03.018]
[8]
Nallagundla, S.; Patnala, S.; Kanfer, I. Comparison of in vitro release rates of acyclovir from cream formulations using vertical diffusion cells. AAPS PharmSciTech, 2014, 15(4), 994-999.
[http://dx.doi.org/10.1208/s12249-014-0130-y] [PMID: 24824173]
[9]
Ng, S.F.; Rouse, J.J.; Sanderson, F.D.; Eccleston, G.M. Validation of Franz cell diffusion experiments and evaluation of drug release through various cellulose membranes. J. Pharm. Pharmacol., 2005, 57, S53-S53.
[10]
Sesto Cabral, M.E.; Ramos, A.N.; Cabrera, C.A.; Valdez, J.C.; González, S.N. Equipment and method for in vitro release measurements on topical dosage forms. Pharm. Dev. Technol., 2014, 7450, 1-7.
[PMID: 25318476]
[11]
Ilić, T.; Pantelić, I.; Lunter, D.; Đorđević, S.; Marković, B.; Ranković, D.; Daniels, R.; Savić, S. Critical quality attributes, in vitro release and correlated in vitro skin permeation in vivo tape stripping collective data for demonstrating therapeutic (non)equivalence of topical semisolids: A case study of “ready-to-use” vehicles. Int. J. Pharm., 2017, 528(1-2), 253-267.
[http://dx.doi.org/10.1016/j.ijpharm.2017.06.018] [PMID: 28602800]
[12]
Gaddam, P.; Muthuprasanna, P.; Suriyaprabha, K.; Manojkumar, J.; Rao, BB.; Jukanti, R. Diffusion cells for measuring skin permeation in vitro. M.S.A.I.J., 2009, 5(3), 277-287.
[13]
Bosman, I.J.; Avegaart, S.R.; Lawant, A.L.; Ensing, K.; de Zeeuw, R.A. Evaluation of a novel diffusion cell for in vitro transdermal permeation: effects of injection height, volume and temperature. J. Pharm. Biomed. Anal., 1998, 17(3), 493-499.
[http://dx.doi.org/10.1016/S0731-7085(97)00238-0] [PMID: 9656161]
[14]
Hanson, R.; Heaney, J. A primer on automating the vertical diffusion cell (VDC). Dissolut. Technol., 2013, 20(2), 40-43.
[http://dx.doi.org/10.14227/DT200213P40]
[15]
Córdoba-Díaz, M.; Nova, M.; Elorza, B.; Córdoba-Díaz, D.; Chantres, J.R.; Córdoba-Borrego, M. Validation protocol of an automated in-line flow-through diffusion equipment for in vitro permeation studies. J. Control. Release, 2000, 69(3), 357-367.
[http://dx.doi.org/10.1016/S0168-3659(00)00306-0] [PMID: 11102676]
[16]
Krishnaiah, Y.S.R.; Xu, X.; Rahman, Z.; Yang, Y.; Katragadda, U.; Lionberger, R.; Peters, J.R.; Uhl, K.; Khan, M.A. Development of performance matrix for generic product equivalence of acyclovir topical creams. Int. J. Pharm., 2014, 475(1-2), 110-122.
[http://dx.doi.org/10.1016/j.ijpharm.2014.07.034] [PMID: 25089511]
[17]
Xu, X.; Al-Ghabeish, M.; Rahman, Z.; Krishnaiah, Y.S.R.; Yerlikaya, F.; Yang, Y.; Manda, P.; Hunt, R.L.; Khan, M.A. Formulation and process factors influencing product quality and in vitro performance of ophthalmic ointments. Int. J. Pharm., 2015, 493(1-2), 412-425.
[http://dx.doi.org/10.1016/j.ijpharm.2015.07.066] [PMID: 26231106]
[18]
Zatz, J.L.; Varsano, J.; Shah, V.P. In vitro release of betamethasone dipropionate from petrolatum-based ointments. Pharm. Dev. Technol., 1996, 1(3), 293-298.
[http://dx.doi.org/10.3109/10837459609022598] [PMID: 9552312]
[19]
Rath, S.; Kanfer, I. A validated IVRT method to assess topical creams containing metronidazole using a novel approach. Pharmaceutics, 2020, 12(2), 119.
[http://dx.doi.org/10.3390/pharmaceutics12020119] [PMID: 32028557]
[20]
Shah, V.P.; Tymes, N.W.; Yamamoto, L.A.; Skelly, J.P. In vitro dissolution profile of transdermal nitroglycerin patches using paddle method. Int. J. Pharm., 1986, 32(2-3), 243-250.
[http://dx.doi.org/10.1016/0378-5173(86)90185-7]
[21]
Mudyahoto, N.A.; Rath, S.; Ramanah, A.; Kanfer, I. In Vitro Release Testing (IVRT) of topical hydrocortisone acetate creams: A Novel approach using positive and negative controls. Dissolut. Technol., 2020, 27(1), 6-12.
[http://dx.doi.org/10.14227/DT270120P6]
[22]
Dong, Y.; Qu, H.; Pavurala, N.; Wang, J.; Sekar, V.; Martinez, M.N.; Fahmy, R.; Ashraf, M.; Cruz, C.N.; Xu, X. Formulation characteristics and in vitro release testing of cyclosporine ophthalmic ointments. Int. J. Pharm., 2018, 544(1), 254-264.
[http://dx.doi.org/10.1016/j.ijpharm.2018.04.042] [PMID: 29684560]
[23]
Non-sterile Semisolid Dosage Forms.Scale-Up and Postapproval Changes (SUPAC-SS): Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research (C.D.E.R.); U.S. Government Printing Office: Washington, DC, 1997.
[http://dx.doi.org/10.1201/9780824741969.ax]
[24]
Habjanič, N.; Kerec Kos, M.; Kristan, K. Sensitivity of different in vitro performance tests and their in vivo relevance for calcipotriol/betamethasone ointment. Pharm. Res., 2020, 37(3), 52.
[http://dx.doi.org/10.1007/s11095-020-2766-5] [PMID: 32043181]
[25]
Alves, T.; Arranca, D.; Martins, A.; Ribeiro, H.; Raposo, S.; Marto, J. Complying with the guideline for quality and equivalence for topical semisolid products: The case of clotrimazole cream. Pharmaceutics, 2021, 13(4), 555.
[http://dx.doi.org/10.3390/pharmaceutics13040555] [PMID: 33920061]
[26]
Raghavan, L.; Brown, M.; Michniak-Kohn, B.; Ng, S.; Sammeta, S. In Vitro release tests as a critical quality attribute in topical product development; Springer: Cham, Switzerland, 2019, p. 36.
[27]
Flynn, G.L.; Shah, V.P.; Tenjarla, S.N.; Corbo, M.; DeMagistris, D.; Feldman, T.G.; Franz, T.J.; Miran, D.R.; Pearce, D.M.; Sequeira, J.A.; Swarbrick, J.; Wang, J.C.T.; Yacobi, A.; Zatz, J.L. Assessment of value and applications of in vitro testing of topical dermatological drug products. Pharm. Res., 1999, 16(9), 1325-1330.
[http://dx.doi.org/10.1023/A:1018997520950] [PMID: 10496646]
[28]
Parera Morell, J.L.; Contreras Claramonte, M.D.; Parera Vialard, A. Validation of a release diffusion cell for topical dosage forms. Int. J. Pharm., 1996, 137(1), 49-55.
[http://dx.doi.org/10.1016/0378-5173(95)04421-3]
[29]
Hauck, W.W.; Shah, V.P.; Shaw, S.W.; Ueda, C.T. Reliability and reproducibility of vertical diffusion cells for determining release rates from semisolid dosage forms. Pharm. Res., 2007, 24(11), 2018-2024.
[http://dx.doi.org/10.1007/s11095-007-9329-x] [PMID: 17530388]
[30]
ICH. Validation of analytical procedures: text and methodology Q2(R1). Guidance, 2005, 1994, 17.
[31]
Lucie, N.; Ludmila, M.; Petr, S. Advantages of application of U.P.L.C. in pharmaceutical analysis. Talanta, 2006, 68(3, 15), 908-918.
[32]
Gosetti, F. Ultra high-performance liquid chromatography-tandem mass spectrometry determination and profiling of prohibited steroids in human biological matrices; Chromatogr, 2013.
[http://dx.doi.org/10.1016/j.jchromb.2012.12.003]
[33]
Shabir, G.A. A practical approach to validation of HPLC methods under current good manufacturing practices. J. Validation Technol., 2004, 10, 210-218.
[34]
U.S. Food and Drug Administration. Draft Guidance on Acyclovir. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_oint_18604_RC03-12.pdf
[35]
U.S. Food and Drug Administration. Draft Guidance on Docosanol Topical Cream. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Docosanol_topical%20cream_NDA
[36]
Shabir, G.A.; John Lough, W.; Arain, S.A.; Bradshaw, T.K. Evaluation and application of best practice in analytical method validation. J. Liq. Chromatogr. Relat. Technol., 2007, 30(3), 311-333.
[http://dx.doi.org/10.1080/10826070601084753]
[37]
U.S. Food and Drug Administration. Draft Guidance on Dapsone Gel. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapsone_Topical%20gel_NDA%20207154_ RV%20Nov%202018.pdf
[38]
European Medicines Agency; Committee for Medicinal Products for Human Use.Draft Guideline on Quality and Equivalence of Topical Products; London, UK, 2018.
[39]
Ueda, C.T.; Shah, V.P.; Derdzinski, K.; Ewing, G.; Flynn, G.; Maibach, H.; Yacobi, A. Topical and transdermal drug products. Pharmacop. Forum, 2009, 35, 750-764.
[40]
Higuchi, W.I. Analysis of data on the medicament release from ointments. J. Pharm. Sci., 1962, 51(8), 802-804.
[http://dx.doi.org/10.1002/jps.2600510825] [PMID: 13907274]
[41]
Higuchi, T. Rate of release of medicaments from ointment bases containing drugs in suspension. J. Pharm. Sci., 1961, 50(10), 874-875.
[http://dx.doi.org/10.1002/jps.2600501018] [PMID: 13907269]
[42]
Sonawane, S.; Gide, P. Application of experimental design for the optimisation of forced degradation and development of a validated stability indicating L.C. method for luliconazole bulk and cream formulation. Arab. J. Chem., 2012, 9, S1428-S1434.
[43]
Rignall, A. ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms. In: ICH Quality Guidelines: An Implementation Guide; Wiley Online Library, 2017.
[44]
Dong, L.; Liu, C.; Cun, D.; Fang, L. The effect of rheological behavior and microstructure of the emulgels on the release and permeation profiles of Terpinen-4-ol. Eur. J. Pharm. Sci., 2015, 78, 140-150.
[http://dx.doi.org/10.1016/j.ejps.2015.07.003] [PMID: 26144369]
[45]
Yüksel, B. Quantitative GC-FID analysis of heroin for seized drugs. Annal. Clin. Analyt.Med., 2020, 11(1), 38-42.
[http://dx.doi.org/10.4328/ACAM.6139]
[46]
Shabir, G.A. Validation of HPLC methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the U.S. Food and Drug Administration, the U.S. Pharmacopoeia and the International Conference on Harmonization. J. Chromatogr. A, 2003, 987, 57-66.
[http://dx.doi.org/10.1016/S0021-9673(02)01536-4] [PMID: 12613797]
[47]
U.S. F.D.A. Draft Product Specific Guidance on Acyclovir Ointment 2012.. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021478.pdf
[48]
U.S. F.D.A. Draft Product Specific Guidance on Benzyl Alcohol 2014. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzyl_alcohol_lot_022129_RC12-14.pdf
[49]
U.S. F.D.A. Draft Product Specific Guidance on Acyclovir Cream 2016. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021478.pdf
[50]
U.S.P. Topical and transdermal drug products- Product performance tests. U.S.P. Pharm. Forum, 2019, 35, 1-12.
[51]
U.S.P. chapter ‹1724› Semisolid drug products performance tests. U.S.P., 2011, 37, 1273-1284.
[52]
Manian, M.; Jain, P.; Vora, D.; Banga, A.K. Formulation and evaluation of the In Vitro performance of topical dermatological products containing diclofenac sodium. Pharmaceutics, 2022, 14(9), 1892.
[http://dx.doi.org/10.3390/pharmaceutics14091892] [PMID: 36145640]
[53]
Shabir, G.A. Step-by-step analytical methods and protocol in the quality system compliance industry. J. Validation Technol., 2004, 10, 314-324.
[54]
Bajaj, S.; Singla, D.; Sakhuja, N. Stability testing of pharmaceutical products. J. Appl. Pharm. Sci., 2012, 2(3), 129-138.
[55]
Validation of analytical procedures: Text and Methodology, Q2(R1); International Conference on Harmonization (ICH): Geneva, Switzerland, 2005.
[56]
Shabir, G.A. HPLC method development and validation for pharmaceutical analysis. PharmaTechnolEur, 2004, 16, 37-49.
[57]
Freeman, S.; Howard, A.; Foley, P.; Rosen, R.; Wood, G.; See, J.A.; Gray, S. Efficacy, cutaneous tolerance and cosmetic acceptability of desonide 0.05% lotion (Desowen ®) versus vehicle in the short‐term treatment of facial atopic or seborrhoeic dermatitis. Australas. J. Dermatol., 2002, 43(3), 186-189.
[http://dx.doi.org/10.1046/j.1440-0960.2002.00592.x] [PMID: 12121395]
[58]
Yüksel, B.; Öncü, T.; Şen, N. Assessing caffeine levels in soft beverages available in Istanbul, Turkey: An LC-MS/MS application in food toxicology. Toxicol. Anal. Clin., 2023, 35(1), 33-43.
[http://dx.doi.org/10.1016/j.toxac.2022.08.004]
[59]
Yüksel, B.; Şen, N. Development and validation of a GC-FID method for determination of cocaine in illicit drug samples. J. res. pharm., 2018, 22(4)
[60]
Greenspan, A.; Herndon, J.H., Jr; Baker, M.D.; Cheney, T. Controlled evaluation of 0.05% desonide lotion and desonide cream in psoriasis. Curr. Ther. Res. Clin. Exp., 1993, 53(6), 614-620.
[http://dx.doi.org/10.1016/S0011-393X(05)80731-3]
[61]
Cornell, R.C.; Baker, M.D. Dermal safety comparison of 0.05% desonide cream and 1.0% hydrocortisone cream. Curr. Ther. Res. Clin. Exp., 1993, 53(4), 356-359.
[http://dx.doi.org/10.1016/S0011-393X(05)80194-8]
[62]
Prawer, S.E.; Katz, H.I.; Herndon, J.H., Jr; Baker, M.D.; Cheney, T. Controlled, bilateral, comparative evaluation of 0.05% desonide lotion and desonide cream in eczematous dermatitis. Curr. Ther. Res. Clin. Exp., 1993, 53(6), 607-613.
[http://dx.doi.org/10.1016/S0011-393X(05)80730-1]
[63]
Phillips, B.M.; Sanen, F.J.; Leeling, J.L.; Hammes, T.L.; Hartnagel, R.E.; Sancilio, L.F.; Lorenzetti, O.J.; Kraus, P.J. The physical, animal and human pharmacologic, and toxicologic properties of desonide, a new, topically active, antiinflammatory steroid. Toxicol. Appl. Pharmacol., 1971, 20(4), 522-537.
[http://dx.doi.org/10.1016/0041-008X(71)90256-0] [PMID: 5143593]
[64]
Zheng, S.; Luo, S.B.; Mei, Y.B.; Guo, J.; Tong, L.J.; Zhang, Q.; Ye, X.Y. Simultaneous determination of rivaroxaban and enalapril in rat plasma by U.P.L.C.–MS/MS and its application to a pharmacokinetic interaction study. Eur. J. Drug Metab. Pharmacokinet., 2019, 44(2), 229-236.
[http://dx.doi.org/10.1007/s13318-018-0504-8] [PMID: 30151746]
[65]
Mohan, T.S.S.J.; Jogia, H.A.; Mukkanti, K. Novel stability-indicating U-HPLC method development and validation for the quantification of perindopril, amlodipine and their impurities in pharmaceutical formulations: Application of QbD approach. Chromatographia, 2020, 83(10), 1197-1220.
[http://dx.doi.org/10.1007/s10337-020-03936-6]
[66]
Harmonised Tripartite Guideline, I.C.H. Stability testing of new drug substances and products, Q1A(R2). Int. Conf. Harmon., 2003, pp. 1-18.
[67]
Mohan, T.S.S.J.; Jogia, H.A.; Mukkanti, K. A stability indicating U-HPLC method for the simultaneous estimation of perindopril, indapamide in the presence of potential impurities: An application of QbD for robustness study. Anal. Chem. Lett., 2020, 10(4), 477-497.
[http://dx.doi.org/10.1080/22297928.2020.1817776]
[68]
Al-Tannak, N. U-HPLC-UV method for simultaneous determination of perindopril arginine and indapamide hemihydrate in combined dosage form: A stability-indicating assay method. Sci. Pharm., 2018, 86(1), 7.
[http://dx.doi.org/10.3390/scipharm86010007] [PMID: 29470453]
[69]
Santa, F.; Sperotto, L.; Braga, M.; Dalcin, T.; Codevilla, C.; Meneghini, L.; Donato, E.; Rolim, C.; Bergold, A.; Adams, A. Development and validation of a simple stability-indicating L.C. method and UVA photostability study of Desonide hair lotion. Curr. Anal. Chem., 2013, 9(4), 659-667.
[http://dx.doi.org/10.2174/15734110113099990011]
[70]
Lopes, S.B.; Sarraguca, J.M. Development of an HPLC assay methodology for a Desonide cream with chemometrics assisted optimisation. Anal. Lett., 2012, 45(11), 1390-1400.
[http://dx.doi.org/10.1080/00032719.2012.675494]
[71]
Minigh, J. Desonide. In: xPharm: The Comprehensive Pharmacology Reference; Elsevier, 2008; pp. 1-5.
[72]
Wang, J.; Zheng, S.; Xu, Y.; Hu, H.; Shen, M.; Tang, L. Development of a novel HPLC method for the determination of the impurities in desonide cream and characterization of its impurities by 2D LC-IT-TOF MS. J. Pharm. Biomed. Anal., 2018, 161, 399-406.
[http://dx.doi.org/10.1016/j.jpba.2018.08.055] [PMID: 30205304]
[73]
Malode, S.B.; Dighe, R.D.; Chaudhari, S.R. Simple UV spectrophotometric determination of Desonide in pure form and pharmaceutical formulation. Inventi Rapid. Pharm Analysis and Quality Assurance, 2012.
[74]
García, M.D.G.; Cañada, F.C.; Culzoni, M.J.; Vera-Candioti, L.; Siano, G.G.; Goicoechea, H.C.; Galera, M.M. Chemometric tools improving the determination of anti-inflammatory and antiepileptic drugs in river and wastewater by solid-phase microextraction and liquid chromatography diode array detection. J. Chromatogr. A, 2009, 1216(29), 5489-5496.
[http://dx.doi.org/10.1016/j.chroma.2009.05.073] [PMID: 19535087]
[75]
Di Pietra, A.M.; Andrisano, V.; Gotti, R.; Cavrini, V. On-line post-column photochemical derivatization in liquid chromatographic—diode-array detection analysis of binary drug mixtures. J. Pharm. Biomed. Anal., 1996, 14(8-10), 1191-1199.
[http://dx.doi.org/10.1016/0731-7085(95)01695-3] [PMID: 8818033]
[76]
Nguyen, T.T.; Kringstad, R.; Aasen, A.J.; Rasmussen, K.E.; Lönnberg, H.; Berg, J-E.; Bartók, M.; Pelczer, I.; Dombi, G. Identification and analysis of a degradation product of the glucocorticoid desonide in ointment. Acta Chem. Scand., 1988, 42b(6), 403-407.
[http://dx.doi.org/10.3891/acta.chem.scand.42b-0403] [PMID: 3195294]
[77]
Nguyen, T.T.; Kringstad, R.; Rasmussen, K.E. Use of extraction columns for the isolation of desonide and parabens from creams and ointments for high-performance liquid chromatographic analysis. J. Chromatogr. A, 1986, 366, 445-450.
[http://dx.doi.org/10.1016/S0021-9673(01)93500-9] [PMID: 3782330]
[78]
U.S. F.D.A. Guidance for industry nonsterile semisolid dosage forms, scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro release testing and in vivo bioequivalence documentation (SUPAC-SS); Guidance for Industry: US, 1997.
[79]
Bao, Q.; Burgess, D.J. Perspectives on physicochemical and in vitro profiling of ophthalmic ointments. Pharm. Res., 2018, 35(12), 234.
[http://dx.doi.org/10.1007/s11095-018-2513-3] [PMID: 30324424]
[80]
Soares, R.F.; Araújo, A.L.D.; Castro, J.L.; Gomes, L.N.L.F.; Pereira, H.M.G.; Aquino Neto, F.R. Quantitative approach to glucocorticosteroids analysis in human urine using LC-MS/MS. J. Braz. Chem. Soc., 2012, 23(11), 2065-2074.
[http://dx.doi.org/10.1590/S0103-50532012005000081]
[81]
Siewert, M.; Dressman, J.; Brown, C.K.; Shah, V.P.; Aiache, J-M.; Aoyagi, N.; Bashaw, D.; Brown, C.; Brown, W.; Burgess, D.; Crison, J.; DeLuca, P.; Djerki, R.; Dressman, J.; Foster, T.; Gjellan, K.; Gray, V.; Hussain, A.; Ingallinera, T.; Klancke, J.; Kraemer, J.; Kristensen, H.; Kumi, K.; Leuner, C.; Limberg, J.; Loos, P.; Margulis, L.; Marroum, P.; Moeller, H.; Mueller, B.; Mueller-Zsigmondy, M.; Okafo, N.; Ouderkirk, L.; Parsi, S.; Qureshi, S.; Robinson, J.; Shah, V.; Siewert, M.; Uppoor, R.; Williams, R. FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms. AAPS PharmSciTech, 2003, 4(1), 43-52.
[http://dx.doi.org/10.1208/pt040107] [PMID: 12916916]
[82]
Shah, V.P.; Elkins, J.S.; Williams, R.L. Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products. Pharm. Dev. Technol., 1999, 4(3), 377-385.
[http://dx.doi.org/10.1081/PDT-100101373] [PMID: 10434283]
[83]
Gineys, N.; Giroud, B.; Vulliet, E. Analytical method for the determination of trace levels of steroid hormones and corticosteroids in soil, based on PLE/SPE/LC-MS/MS. Anal. Bioanal. Chem., 2010, 397(6), 2295-2302.
[http://dx.doi.org/10.1007/s00216-010-3787-4] [PMID: 20449575]
[84]
Beotra, A.; Reddy, I.M.; Jain, S.; Ahi, S. A simple and rapid ESI-LC-MS/MS method for simultaneous screening of doping agents in urine samples. Indian J. Pharmacol., 2009, 41(2), 80-86.
[http://dx.doi.org/10.4103/0253-7613.51347] [PMID: 20336223]
[85]
Harmonised Tripartite Guideline, I.C.H. Validation of analytical procedures: Text and methodology, Q2(R1). Int. Conf. Harmon., 2005, pp. 1-13.
[86]
Patient assessment of Desonide hydrogel for the treatment of mild to moderate atopic dermatitis. J. Am. Acad. Dermatol., 2009, 60(3), AB69.
[87]
Lopes, S.B.; Sarraguça, J.M.; Prior, J.A.V.; Lopes, J.A. Development of an HPLC assay methodology for a Desonide cream with chemometrics assisted optimization. Anal. Lett., 2012, 45(11), 1390-1400.
[http://dx.doi.org/10.1080/00032719.2012.675494]
[88]
Antonow, M.B.; Lorenzoni, R.; Barbosa, G.M.; Ourique, A.F.; Gomes, P.; Raffin, R.P. Development and physicochemical characterization of Desonide-loaded nanocapsule suspensions. Adv. Mater. Sci. Eng., 2016, 2016, 1-12.
[http://dx.doi.org/10.1155/2016/7395896]
[89]
Mayurkumar, D.J.; Chaudhary, A.B.; Pandya, C.H. Development and validation of Rp-Hplc method for estimation of desonide in presence of sorbic acid. World J. Pharm. Pharm. Sci., 2018, 7(6), 666-678.
[90]
Seelam, J.; Ismail, Y. A review on in-vitro release testing methods for topical dosage forms. J. Drug Alcohol. Res., 2023, 12, 1-8.

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy