DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METOPROLOL, TELMISARTAN AND CLINIDIPINE IN TABLETAbstract
RP-HPLC method has been developed for separation and quantification of Metoprolol succinate, Telmisartan, and Clinidipine using Phenomenex Luna C18 column (150 mm × 4.6 mm, 5 µm) as a stationary phase with security guard cartridge C18 (4 × 3 mm) and acetonitrile: methanol: phosphate buffer pH 7.5 (45:30:25) as a mobile phase by isocratic elution at the flow rate of 1.0 ml/min. The detection was carried out at 229 nm. The drugs are eluted at retention times 2.0, 2.8, and 6.8min for telmisartan, metoprolol succinate, and clinidipine, respectively. The method is linear in the range of 10-80 μg / ml, 6.25-50 μg / ml, and 2.5-20 μg / ml with regression coefficients 0.997, 0.995, and 0.999 respectively for telmisartan, metoprolol succinate, and clinidipine. The method is precise within the acceptable limits (% RSD- 1.22). The proposed method showed linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance criteria of ICH. The method can be applied for the routine analysis of pharmaceutical formulations.
M. S. Kalshetti * and S. S. Kankure
Department of Pharmaceutical Quality Assurance, D. S. T. S. Mandal’s College of Pharmacy, Solapur, Maharashtra, India.
13 March 2020
23 October 2020
31 October 2020
01 March 2021