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Current
Pharmaceutical Analysis
ISSN: 1573-4129
Current Pharmaceutical
Analysis
Volume 7, Number 1, February 2011
Contents
5-Fluorouracil - Characteristics and Analytical Determination
Pp. 1-11
Barbora Hansova, Stanislav Synek and Radka Opatrilova
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Analysis and Determination of Anti-diabetes Drug
Acarbose and its Structural Analogs Pp. 12-20
Ya-Jun Wang, Yu-Guo Zheng, Ya-Ping Xue, Yuan-Shan Wang
and Yin-Chu Shen
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Development and Validation of a HPLC Method for
Simultaneous Determination of Dapivirine and DS003 in Combination
Microbicide Tablet Pp. 21-26
Jyoti Gupta, Asma Othman, Jason Qihai Tao and
Sanjay Garg
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Article]
A Review on Various Analytical Methods on Some
Alpha Adrenergic Antagonists Pp. 27-41
Alankar Shrivastava and Vipin B. Gupta
[Abstract] [Purchase
Article]
Quantitation of Lumefantrine in Biological Matrices
Pp. 42-46
Wahajuddin, Sheelendra P. Singh, Shio K. Singh and
Girish K. Jain
[Abstract] [Purchase
Article]
Novel Chiral LC Methods for the Enantiomeric
Separation of Bicalutamide and Thalidomide on Amylose Based
Immobilized CSP Pp. 47-53
I.V. Soma Raju, P. Raghuram and J. Sriramulu
[Abstract] [Purchase
Article]
Pharmaceutical Counterfeiting and Analytical
Authentication Pp. 54-61
Ram Talati, Saumil Parikh and Y.K. Agrawal
[Abstract] [Purchase
Article]
A Review on Need and Importance of Impurity Profiling
Pp. 62-70
Sunny Nagpal, Karan, Ashutosh Upadhyay, T. R. Bhardwaj
and Arti Thakkar
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Abstracts
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5-Fluorouracil - Characteristics and Analytical Determination
Barbora Hansova, Stanislav Synek and Radka Opatrilova
5-fluorouracil (5-FU or f5U) is a pyrimidine analogue,
and is used as an antineoplastic drug. Working with antineoplastic
drugs constitutes a health hazard for the people who handle
them, mainly because of their mutagenicity, teratogenicity
and carcinogenicity. This is the reason, why the determination
of antineoplastic drugs in wipe samples obtained from the
hospital departments, where antineoplastic drugs are prepared
or administered is growing in importance.
5-fluorouracil has some unusual pharmacological characteristics,
which make it suitable for therapeutic drug monitoring. Thus,
its determination in plasma and other body fluids or in urine
is important, too. Like other drugs, 5-fluorouracil is also
determined in formulations during quality control or stability
studies.
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Analysis and Determination of Anti-diabetes
Drug Acarbose and its Structural Analogs
Ya-Jun Wang, Yu-Guo Zheng, Ya-Ping Xue, Yuan-Shan Wang
and Yin-Chu Shen
Acarbose is a clinically useful drug for the treatment
of type II insulin-independent diabetes as a hypoglycemic
agent. This minireview summarized detection and separation
methods for the analysis and determination of anti-diabetes
drug acarbose and its structural analogs, including HPLC,
enzyme-based biosensor and capillary electrophoresis. Besides
the protocol, principle behind each technique is presented
together with its strengths and weaknesses. Finally, we analyze
the future trends in the acarbose analysis.
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Development and Validation of a HPLC Method for Simultaneous
Determination of Dapivirine and DS003 in Combination Microbicide
Tablet
Jyoti Gupta, Asm Othman, Jason Qihai Tao and
Sanjay Garg
A reverse phase liquid chromatographic
analytical method was developed for the simultaneous determination
of Dapivirine and DS003 content in tablet dosage form. The
chromatographic separation was achieved by using a C18
column with mobile phase containing a gradient mixture of
0.05% v/v trifluoroacetic acid in water as mobile phase A
and acetonitrile as mobile phase B at a flow rate of 0.5 ml/min.
Both of the analytes were quantified with a UV detector at
245 nm. Dapivirine and DS003 were subjected to the stress
conditions of oxidation, acid and base hydrolysis and thermolysis.
The analytes were found to be stable under acidic and thermal
conditions. Dapivirine was not significantly affected by base
hydrolysis but was severely affected by oxidative conditions.
DS003 was significantly affected by both oxidation and base
hydrolysis. The stability-indicating capability of this method
was demonstrated by adequate separation of the degradation
peaks from those of the actives in the stress degraded samples.
The method was validated for linearity, specificity, system
suitability, precision and accuracy in accordance with ICH
guidelines. The proposed method was applied to quantitate
Dapivirine and DS003 in drug-excipient compatibility studies,
assay of the tablets and stability studies of Dapivirine and
DS003 tablets.
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A Review on Various Analytical Methods on
Some Alpha Adrenergic Antagonists
Alankar Shrivastava and
Vipin B. Gupta
Background: Although
initially introduced for the management of hypertension, αl-adrenergic-receptor
antagonists (αl-blockers)
have become the standard of care for the medical management
of benign prostatic hyperplasia (BPH) related lower urinary
tract symptoms (LUTS). Alpha-blockers (alfuzosin, tamsulosin,
doxazosin, prazosin and terazosin) relax the smooth muscles
in the prostate and are indicated for the symptomatic treatment
of BPH due to evidence of their positive and rapid effect
on LUTS. However, these agents have the potential to produce
orthostatic hypotension and other blood pressure-related adverse
effects in normotensive patients and in those receiving concurrent
treatment with other antihypertensive agents. As a result,
more "uroselective," less vasoactive αl-blockers
have been developed such as tamsulosin and alfuzosin.
Objective: The presented review provides
information about the various analytical methods available
in the literature to the scientists and health professionals
engaged in research relating these drugs such as clinical
trials or developing new formulations. Various analytical
methods for the estimation of these drugs in bulk or in various
matrices like blood, serum, plasma, alone or in combination
with other drugs is discussed.
Methods: Relevant articles were identified
through a search of the English-language literature indexed
in MEDLINE, PubMed, Sciencedirect and the proceedings of scientific
meetings from 1977 to 2010. The search terms were benign estimation
of alpha one blockers, determination of prazosin, terazosin,
tamsulosin, doxazosin, alfuzosin. Similarly HPLC
and Spectroscopy methods for estimation of prazosin, terazosin,
tamsulosin, doxazosin, alfuzosin.
Results: Total 57 analytical methods were
found. 11 spectrophotometry, 39 chromatographic methods including
2 ESI MS/MS, 1 ESI MS, 2 HPTLC, 3 TLC, 17 HPLC with UV, 9
with fluorescence, 1 with electrochemical detection, 4 with
MS detector. Other than this 3 voltametry, 1 method each for
radioreceptor assay, polarography, capillary electrophoresis
and potentiometry titrations were found.
Conclusion: Radioreceptor assay, LC-MS, UPLC-MS
methods were found to be the most sensitive for prazosin,
terazosin and doxazosin respectively. Likewise, HPLC-MS-MS
methods was found as most sensitive method for estimation
of tamsulosin and alfuzosin.
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Quantitation of Lumefantrine in Biological
Matrices
Wahajuddin, Sheelendra P. Singh, Shio K. Singh and
Girish K. Jain
It is the first systematic review to compare
the bioanalytical methods to quantify the highly protein bound
antimalarial, lumefantrine. We searched MEDLINE, SCIENCE DIRECT,
GOOGLE and hand-searched journals and PhD theses. The inclusion
criteria were, use of validated bioanalytical for quantification
of lumefantrine in preclinical studies, healthy human volunteers
and malaria patients. Ten bioanalytical methods were eligible
and gave information on all separation and quantification
domains considered in the review. There are ten previously
published methods for quantitative analysis of lumefantrine
in biological matrices comprising seven methods using HPLC-UV
and three tandem mass spectrometric (LC-MS/MS) detection.
Most of the HPLC methods incorporated complex extraction procedure
and long run time. Bioanalyst(s) may choose the bioanalytical
method out of reported ones depending upon the study objectives
and rapidity, sensitivity and ease in sample preparation required.
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Novel Chiral LC Methods for the Enantiomeric
Separation of Bicalutamide and Thalidomide on Amylose Based
Immobilized CSP
I.V. Soma Raju P. Raghuram and
J. Sriramulu
Fast chiral liquid chromatographic methods
are developed for the separation of bicalutamide and thalidomide
enantiomers in bulk drug samples in an elution time of about
15 min. The chromatographic separation was carried out on
various solvents using an amylose 3,5-dimethylphenylcarbamate
immobilized onto silica gel (Chiralpak®-IA).
The resolution (Rs) between the enantiomers is found to be
greater than 1.5 in the developed method. Chiralpak®-IA
column played a key role in achieving chromatographic resolution
between the enantiomers and also in enhancing chromatographic
efficiency. The column's compatability to non standard chromatographic
solvents is checked and found suitable.
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Pharmaceutical Counterfeiting and Analytical
Authentication
Ram Talati, Saumil Parikh and Y.K. Agrawal
Counterfeiting is deeply rooted as it is being practiced
since ancient times. It has been in this world for a long
time, and is rapidly growing with the newly available growth
in science and technology. The review provides an evidence
of the growth and rising concerns of counterfeiting. Counterfeiting
has been fuelled by corruption, inability to control, and
also a rise in consumers who resort to such goods in the developing
countries. The control of such piracy practice is indispensable
and thus governments and internationally recognized institutions
have taken measures to limit its spread and abolish it. The
manufacturers are at a greatest loss from it and thus have
started anti-counterfeiting practice. Such practice is highly
recommended in healthcare practices where much harm is done
to the customers. Analytical techniques and instruments have
found a greater importance in the detection, identification,
and differentiation of the counterfeit products. Manufacturers
utilize anti-counterfeiting techniques to keep track of their
product, quarantine, and identify their product from the duplicated,
pirated or counterfeit products. The various anti-counterfeiting
techniques are given in the review.
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A Review on Need and Importance of Impurity Profiling
Sunny Nagpal, Karan, Ashutosh Upadhyay, T. R. Bhardwaj
and Arti Thakkar
Drug formulations contain active pharmaceutical
ingredients (APIs) and excipients. APIs present in the formulations
contain some undesired impurity, which affects purity of the
APIs. Therefore, with along % purity, impurity profiling is
also needed to be carried out of all the APIs. Impurity profiling
describes the account or description of maximum possible types
of identified or unidentified impurities present in any APIs.
These impurities can be API related impurities, process related
impurities or stability related impurities. API related impurities
include stereochemistry, crystallization, and functional group
of APIs. Process related impurities include chemicals, reagents,
catalysts, residual solvents, synthetic intermediate products,
by product, degradation products, method conditions related
impurities, and formulation related impurities. Stability
related impurities include degradation or transformation of
APIs, mutual interactions among APIs, excipients present in
drug product. Presence of these unwanted impurities may influence
bioavailability, safety and efficacy of APIs. Various regulatory
authorities such as ICH, USFDA etc., have specified various
limits for impurities in APIs. Along with the routine use
of authentic markers and analytical techniques, isolation
and characterization of impurities are required for acquiring
the data that establishes biological safety and efficacy.
In the recent trends impurity profiling emerges out as a mandatory
requirement for a new drug application. The present review
describes probable sources of impurities, need for impurity
profiling and detailed techniques of characterization and
quantitation of impurities. Thus, this review is an attempt
to understand concept of impurity profiling and its various
aspects.
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