Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Determination of Selected Drugs Using Green Assessment in Bulk and Pharmaceutical Dosage Form

A new, validated, and selective RP-HPLC technique was established for quantitative estimation of Metformin, Teneligliptin, and Pioglitazone in the pharmaceutical formulations. Reverse-phase HPLC was used to separate and quantify Metformin, Teneligliptin, and Pioglitazone. The method utilized a ZORBAX Eclipse Plus C۱۸ column, a mobile phase of ۰.۰۱N potassium di-hydrogen phosphate buffer, acetonitrile, and methanol, and operated at a flow rate of ۰.۹ ml/min and a wavelength of ۲۲۰ nm. The drugs were successfully separated with retention times of ۲.۳۶۵, ۲.۹۷۰, and ۳.۶۴۲ minutes, respectively. The developed method was successfully validated for Specificity, System suitability accuracy, precision, linearity, limit of detection, limit of quantification, and robustness. The drug composition was subjected to acidic, base, neutral hydrolysis, thermal, and photolytic conditions. Thus, stressed samples are analysed by the proposed analytical method. The developed method holds potential for application in quality control analysis and identification of degradation. The developed analytical method was assessed with a green analytical metric tool and found that the method was green.

Keywords:

Metformin , Teneligliptin , Pioglitazone , Method Development , Validation