ABSTRACT

Reverse phase High performance liquid chromatography method has developed and validated for the simultaneous analysis of glibenclamide, metformin hydrochloride and pioglitazone hydrochloride in tablet dosage form. The chromatographic separation of drugs was achieved at ambient temperature with isocratic mode by using C18 Hypersil BDS (150 x 4.6 mm, 5 µm) column with mobile phase containing acetonitrile: 0.1M potassium dihydrogen orthophosphate buffer (pH 4.5 adjusted with 10% sodium hydroxide solution) in the ratio 55: 45 v/v at flow rate 0.7 mL/min. The run time was 11 min and injection volume 20 µL. The eluent was monitored at 255 nm by using PDA detector. The method was validated as per ICH guidelines. The selected chromatographic conditions effectively separated metformin, pioglitazone and glibenclamide with retention time 2.1, 3.0 and 7.1 min respectively. The mean percentage recoveries were found in the range of 98-102 % which shows accuracy of the developed method. The linearity range for metformin, Pioglitazone and glibenclamide is found in the range of 50-400 µg/mL, 1-12 µg/mL and 0.5-4 µg/mL respectively. Limit of detection were 5, 0.1, 0.05 µg/mL and limit of quantification were 15, 0.3, 0.15 µg/mL for metformin, Pioglitazone and glibenclamide, respectively. The developed method was found to be specific, accurate, precise and economic. Keywords: Metformin Hydrochloride, Pioglitazone Hydrochloride, Glibenclamide, RP-HPLC and Validation
Publication date: 01/05/2022

https://ijbpas.com/pdf/2022/May/MS_IJBPAS_2022_5861.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.5.5861