Abstract

A VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Kharat S.S.*, Andhale S.P. and Saudagar R.B.

ABSTRACT

The simple, selective, accurate, efficient and reproducible Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for analysis of Cilnidipine in bulk and tablet dosage form. The separation was carried out on Hexon C18 (250mm x 4.6ID, Particle size: 5 micron) in isocratic mode column using the mobile phase composition was Methanol and Water (85:15 % v/v) adjusted pH to 3.5 with orthophosphoric acid. The injection volume was 20μl at flow rate of 1.0 ml/min, effluent was detected at 243 nm with a sharp peak obtained for CIL at a retention time of 4.658 ± 0.01 min. Linearity was observed in the concentration range from 10 to 50 μg/ml for Cilnidipine with a correlation coefficient of (r2) 0.9979. The percentage recovery was within the range between 98.86 to 102.11 % for Cilnidipine. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. The method was validated according to ‘The International Council for Harmonisation’ guidelines in terms of linearity, accuracy, precision and specificity. Hence, the proposed method can be utilized for routine quality control of Cilnidipine in bulk and tablet dosage form.

Keywords: ‘The International Council for Harmonisation’ (ICH) guidelines, Cilnidipine (CIL), ultraviolet detection, validation, reverse phase high performance liquid chromatography.