Title:Development and Validation of New HPLC Method for the Determination of Imidazolidinyl Urea in Topical Formulation
Volume: 20
Issue: 5
Author(s): Gamze Ergin Kızılçay*, Sıdıka Ertürk Toker and Dilek Matur
Affiliation:
- Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Istanbul, 34116, Turkey
Keywords:
Imidazolidinyl urea, HPLC, DAD, topical formulation, validation, antimicrobial preservative.
Abstract:
Introduction: In this study, a new, simple, selective, and fast liquid chromatographic
method has been developed and validated for the determination of imidazolidinyl urea used as an
anti-microbial agent in topical formulation.
Methods: The developed HPLC method using a diode array detector for the determination of imidazolidinyl
urea was applied to the topical formulation. Imidazolidinyl urea in the sample was analyzed
in the cyano column (250 x 4,6 mm, 5 μm i.d.) under chromatographic conditions, where
the flow rate was determined as 1.0 mL/min. The column oven was 40.0°C, and imidazolidinyl
urea was detected at 210 nm. Isocratic application of acetonitrile-water (25:75, v/v) was used as
the mobile phase system. The validation of the developed method was performed according to the
International Conference on Harmonisation guidelines Q2 (R1).
Results: The linearity range of the imidazolidinyl urea was 0.050-0.150 mg/mL, and the limits of
detection and quantification were calculated to be 62.5x10-6 mg/mL and 125x10-6 mg/mL, respectively.
Assay recovery and precision of imidazolidinyl urea from topical formulation at 0.050,
0.100, and 0.125 mg/mL concentrations were evaluated. The mean recoveries for imidazolidinyl
urea in the topical formulation were calculated as 98.857-104.560%.
Conclusion: The validated method was successfully applied to the determination of imidazolidinyl
urea in a topical formulation. The proposed method is reproducible and reliable and can be
used safely for routine analysis.
