Monday , 20 January 2020

Analytical Method Development and Validation for the Simultaneous Estimation of Metformin and Glibenclamide by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Ramanjaneyaulu*, Devika Subrramaniyan.G, Ramesh petchi Rajendran
Bomma Institute of Pharmacy, Khammam, Telangana, India

A B S T R A C T
A reverse phase high performance liquid chromatographic method was developed for the determination of Metformin and Glibenclamide in bulk and Pharmaceutical dosage form. The separation was acheived by using C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) mixed phosphate buffer: ACN and detection wavelength was 210 nm. The instrument used was Shimadzu HPLC with photo diode array detector having Spinchrome software version. The retention times were found to be 2.267 & 3.303 min. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study was found in concentration range of 150 ppm to 350 ppm for Metformin and 1.5 ppm to 3.5 ppm for Glibenclamide and correlation coefficient (r2) was found to be 0.995 and 0.997, % recovery was found to be 100.02% and 100.24% respectively and % RSD for intermediate precision was 1.68 and 1.70 respectively. The precision study was precise, robust, and repeatable.LOD was found to be 24.89 µg/ml for Metformin and 0.020 µg/ml for Glibenclamide. LOQ was found to be 75.44 µg/ml for Metformin and 0.061µg/ml for Glibenclamide.
Keywords: Metformin, Glibenclamide, RP-HPLC, LOD and LOQ

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