Sunday , 3 March 2024

Analytical Method Development and Validation for the Simultaneous Estimation of Pioglitazone and Metformin in Bulk and Formulation by Using RP- HPLC

Dr. Gampa Vijay Kumar1*, P. Sowjanya2, Gone Harish3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

2Professor KGR Institute of Technology and Management, Kesara, Rangareddy, Telangana, India.
3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A new method was established for simultaneous estimation of Pioglitazone and Metformin by RP-HPLC method. The chromatographic conditions were success fully developed for the separation of Pioglitazone and Metformin  by using Thermosil C18 column (4.0×125mm) 5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: Sodium acetate bufferpH 3 (pH was adjusted with orthophosphoricacid), detection wavelength was 252nm. HPLC instrument is Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.566mins and 3.417mins. The % purity of Pioglitazone andMetformin was found to be 101.27% and 99.97% respectively. The system suitability parameters forPioglitazone and Metformin  such as theoretical plates and tailing factor were found to be 4668, 1.3 and 6089 and 1.2, the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study Pioglitazone and Metformin was found in concentration range of 5µg-25µg and 50µg-250µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.86 and 0.82, % RSD for intermediate precision was 0.44 and 0.19 respectively. The precision study was precise, robust, and repeatable.LOD value was 3.17 and 5.68, and LOQ value was 0.0172 and 0.2125 respectively.Hence the suggested RP-HPLC.
Keywords: Thermosil C18 column, Pioglitazone and Metformin , RP-HPLC

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