ABSTRACT

The main aim of this research work is to estimate and validate the Metoprolol Succinate and Ramipril in bulk and marketed formulation. Method development was carried out by autosampler HPLC Shimadzu 2030C 3D plus was used with stationary phase YMC column (150 × 4.6 mm, 3 µm) with ambient temperature. The mobile phase-A consisting of 0.1 ml orthophosphoric acid in 100 ml water and mobile phase-B consisting of Acetonitrile in gradient mode was pumped into the column at a flow rate of 1.0 mL/min. The injection volume was 20 µL with photo diode array detector at 225 nm. Validation was done according to ICH Q2 (R1) guidelines. Linearity for Metoprolol Succinate was 50-250µg/mL, and Ramipril was 10-50µg/mL with the correlation coefficient [R2 ] 0.9998and 0.9994. The percentage recoveries were found to be within limits of acceptance criteria between the ranges of 98-102%. Precision results were found to be within limits and method was found to be robust with %RSD limit of NMT 2.0. The method was validated statistically and was applied successfully for estimation of Metoprolol Succinate and Ramipril. All the parameters like theoretical plates, resolution, tailing factor and % RSD was within the acceptance limits. Hence the proposed method can be successfully applied to routine analysis. Keywords: Metoprolol Succinate, Ramipril, RP-HPLC, Validation
Publication date: 01/02/2022

https://ijbpas.com/pdf/2022/February/MS_IJBPAS_2022_5856.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2022/11.2.5856