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A validated HPTLC method for determination of propyl thiouracil in the presence of its impurities
Published in Global Research Online
Volume: 37
Issue: 2
Pages: 114 - 118
In the current trend various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the identification and quantitation of impurities in Active Pharmaceutical Ingredient's (API's) and it is now emerging as a mandatory requirement for the new drug application. Hence their level should be controlled and monitored. Thus a simple sensitive High performance thin layer chromatographic (HPTLC) method for estimation of Propyl thiouracil and its process related impurities has been developed. Propyl thiouracil and its impurities were separated and identified on silica Gel 60 F254TLC plates with Hexane: Acetone: Ethyl Acetate: Formic acid 6:4:1:0.5 (v/v) as mobile phase. The plates were developed to a distance of 8 cm and quantification was performed at $\lambda$ = 254 nm. The method was validated for linearity, accuracy, precision and robustness according to ICH guidelines. The calibration plots were linear in the range 2500-5625 and 50-112.5 ng/band for API and its three impurities respectively. Here recovery value for API and impurities were found to be in the range of 99.99 to 100.75 % with % RSD value always less than 2. Hence the developed method was found to be simple, sensitive, accurate and precise which can be used for propyl thiouracil impurity profile study and for routine analysis of propyl thiouracil from its dosage forms and for IPQC study during manufacturing of its formulations.
About the journal
JournalInternational Journal of Pharmaceutical Sciences Review and Research
PublisherGlobal Research Online
Open AccessNo