分析与生物分析技术杂志

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Determination of Glipizide, Glibenlamide and Glimeperide in a Tablet Dosage Form in the Presence of Metformin Hydrochloride by Ion Pair –Reversed Phase Liquid Chromatographic Technique

B. Udaykumar Rao and Anna Pratima Nikalje

The present work describes the development and validation of an isocratic HPLC method for the stability indicating assay of Glipizide (GPZ), Glibenclamide (GBD) and Glimeperide (GMD) in the presence of Metformin hydrochloride (MET) in pharmaceutical dosage forms using ion pair-reversed phase liquid chromatographic Technique. The ion pairing agent used was tetrabutyl ammonium hydrogen sulphate (TBHS). The TBHS 0.030 molar solution in water with pH 6.0 used as buffer. The composition of buffer with acetonitrile used was 50:50 (v/v) on reversed phase column bonded with octadecyl silane. The wave length used was 225 nm. The resolution between the closest peaks Glimeperide and Glibenclamide was more than 1.5 and all the three drugs gives a linear response (r2>0.999). The method used for all the three substances were found selective, precise, accurate and robust. The method can be used for quality control assay of the bulk and in finished dosage form as single component and combine with Metformin hydrochloride. The purpose of the method to study individually the stability of Glipizide, Glibenclamide and Glimeperide in the presence of Metformin hydrochloride as any such method is not reported so far.