Abstract

Tadikonda Rama Rao* and S. Hashika Keerthana

ABSTRACT

An accurate, precise, simple, efficient and reproducible, isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Cilnidipine and Telmisartan in bulk and combined pharmaceutical tablet dosage forms. Cilnidipine and Telmisartan were separated by using a Symmetry ODS C18 (4.6mm×150mm) 5µm Particle Size; Waters Alliance e2695 HPLC system with 2998 PDA detector and the mobile phase contained a mixture of Methanol: 0.1% Orthophosphoric acid (64:36% v/v). The flow rate was set to 1 ml/min with the responses measured at 224 nm. The retention time of Cilnidipine and Telmisartan was found to be 2.808 min and 3.880 min respectively with resolution of 5.68. Linearity was established for Cilnidipine and Telmisartan in the range of 20-100 µg/ml for Cilnidipine and 60-140 µg/ml for Telmisartan with correlation coefficient 0.999. The percentage recovery was found to be 100.30% for Cilnidipine and 100.21% for Telmisartan respectively. Validation parameters such as specificity, linearity, precision, accuracy and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The developed method was successfully applied for the quantification of bulk and active pharmaceutical ingredient present and in combined tablet dosage form.