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DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TRIHEXYPHENIDYL, CHLORPROMAZINE AND TRIFLUOPERAZINE IN PHARMACEUTICAL FORMULATIONS
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| Author:
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VIJAY SINGH, DIVAKAR T.E
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| Abstract:
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A simple, rapid and accurate stability indicating High performance Liquid Chromatographic method was developed
and validated for the simultaneous determination of Trihexyphenidyl (THP), Chlorpromazine (CLP) and
Trifluoperazine (TFP) in pure and its Pharmaceutical formulations using Inertsil ODS C18 column (250mmx 4.6 mm,
5µ) and Methanol: Acetonitrile: Acetate Buffer 80:15:05 v/v as mobile phase at pH 6.1 and flow rate of 1 ml/min with
isocratic elution. The eluted compounds were detected at a wavelength 239 nm. The retention times of THP, CLP
and TFP are found to be 4.0, 5.9 and 7.7 min respectively with a correlation coefficient 0.999 each. The linearity
range was found to be 0.4-4, 10-100 and 1-10 µg/ml for THP, CLP and TFP. The percentage recovery was found to
be in range of 98.43 – 99.90%, 98.14-99.94 and 98.22-99.98% for THP, CLP and TFP respectively. Standard drugs
were subjected to acid base, hydrolysis, Oxidation, photolytic and thermal degradation conditions. The degradation
products of THP, CLP and TFP were well resolved from the pure drug with significant differences in their retention
time values. This validated method was applied for the simultaneous estimation of THP, CLP and TFP in commercially
available formulation sample.
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| Keyword:
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Trihexyphenidyl, Chlorpromazine, Trifluoperazine, HPLC method, ICH guidelines
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2018.10.04.015
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| Download:
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