In Vitro Drug Release Study of S(-) Metoprolol Succinate Tablet by RP-HPLC Analysis and Forced Degradation Assessment of Adalimumabexposed to Elevated Temperature and Agitation Using SDS-Page Analysis

Abstract

S(-)Metoprolol Succinate is an orally administrated, beta blocker drug used in the treatment of Angina (heart-related chest pain) and Hypertension (high blood pressure). A simple, specific, linear, accurate, robust, sensitive and precise high-performance liquid chromatography method was developed for S(-) Metoprolol Succinate. The column used Hypersil BDS C8, (250 x 4.6) mm, column packed with 5μm particles, mobile phase was a mixture of buffer solution, and acetonitrile in the ratio of 75:25% v/v/v was pumped at a flow rate of 1 ml/min. Detector wavelength was monitored at 280 nm, and the injection volume was 100μL and run time was kept 12 min. The developed method was validated in terms of linearity, range, accuracy, precision, repeatability and specificity, robustness as per ICHQ2(R1). The method had more linearity in the concentration ranges of (0.6 to 75μg/mL) having with regression coefficients of 1.000. The recovery ratios were in the range of 95-105%%. The precision was evaluated by studying intermediate precision and repeatability. precision was performed in a similar way another day. The %RSD values for method precision were 0.07% and intermediate precision were 0.4% respectively.