DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-UFLC METHOD FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND METFORMIN HClAbstract
A Simple, sensitive, precise, and stability-indicating method was developed for the simultaneous estimation of Telmisartan & Metformin HCl in bulk & prepared formulation. The column used for the separation was Phenomenex C18 (150 × 4.6, 5 µ), with a mobile phase containing Phosphate buffer pH 3.6 & acetonitrile (30:70% v/v) at a flow rate of 0.5 ml/min. The retention time of Telmisartan was 6.098 min & Metformin HCl was 2.828 min, respectively. The detection of drugs was carried out at 249 nm. The linearity was carried out at 10-60 µg/ml for Telmisartan & Metformin HCl, in bulk and prepared tablet dosage form. LOD and LOQ were calculated as 0.773 µg/ml and 1.286 µg/ml for Telmisartan, 2.345 µg/ml, and 3.898 µg/ml for Metformin HCl. The drugs were stressed in conditions such as Acidic, Basic, Thermal, Photolytic, and oxidative conditions. All the developed parameters were within the acceptance criteria of ICH guidelines. The developed method was simple, precise, specific, robust and rapid for the quality control analysis for simultaneous determination of Telmisartan & Metformin HCl, respectively.
C. U. Tirodkar, M. S. Palled *, M. K. Chauhan, S. S. Suryawanshi, S. Majukar and S. S. Jalalpure
Department of Pharmaceutical Chemistry, KLE College of Pharmacy, JNMC Campus, Belagavi, Karnataka, India.
05 July 2020
24 November 2020
06 May 2021
01 July 2021