Bioanalytical Method Development and Validation for Metoprolol Succinate and Telmisartan Using UV Spectro-Photometry and RP-HPLC

An accurate, precise and reproducible bioanalytical UV-spectrophotometric and liquid chromatographic assay method were developed and validated for the determination of metoprolol succinate (MET) and telmisartan (TEL) in blood plasma using protein precipitation technique. Spectrophotometric estimation was done by simultaneous equation method followed by rst order derivative method using 50% methanol as solvent. In this method λ_{max for MET and TEL were selected at 240.5 nm and 237.5 nm respectively. RP-HPLC analysis was carried out using Prontosil C-18 column (4.6 x 250 mm, 5 μ particle size) and mobile phase composed of methanol:acetonitrile:phosphate buffer (pH-5) in ratio of 35:35:30 v/v/v, at a ow rate of 1.0 mL min^-1 and chromatogram was recorded at 225 nm. Linearity of drugs for blood plasma was evaluated over the concentration range of 5-25 μg mL^-1 and 8-40 μg mL^-1 for MET and TEL in both UV spectrophotometric and RP-HPLC method (the value of r² = 0.999 by both the methods for MET and TEL). The developed methods were validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Therefore, both the methods can be used for routine monitoring of MET and TEL in industry in the assay of bulk drug, in plasma and tablets.}