DEVELOPMENT AND VALIDATION OF NOVEL UV AND RP-HPLC METHODS FOR DETERMINATION OF CILNIDIPINE (A NEW GENERATION Ca CHANNEL BLOCKER) IN PHARMACEUTICAL DOSAGE FORM

An accurate and precise High-Performance Reversed-Phase Liquid Chromatographic and UV spectrophotometric methods were developed and validated for the quantitative determination of Cilnidipine, a novel generation Ca channel blocker in the pharmaceutical dosage form. Good quality chromatographic separation of Cilnidipine was carried out by using thermo scientific model C18 Column (4.6 mm i.d. × 250 mm, 5 µm particle size) (based on 99.999% ultra-high purity silica) using mobile phase consisting acetonitrile: methanol (50:50% v/v) at flow rate of 1.0 mL/min. The λ_max of the Cilnidipine in methanol (as a solvent) was found to be 242 nm. The drug following linearity in the concentration range of 2-10 µg/mL with a correlation coefficient value of 0.9999 for both UV and HPLC methods. The regression equation for Cilnidipine UV method was found to be Y = 0.081x + 0.0017 and for HPLC method was Y = 25517x – 4755. LOD and LOQ were found as 0.15095 µg/mL and 0.45742 µg/mL for UV method and for HPLC method it was found to be 0.003 µg/mL and 0.0099 µg/mL.  The developed methods were validated in pursuance of ICH Q2 (R1) guidelines. Both the methods were linear, precise, accurate with recoveries in the range of 98-102% and low values of % RSD are indicative of the accuracy of the method. The detailed quantitative results of this study show that this method is simple, quick, precise, accurate, sensitive, cost-effective and robust.  Thus, the developed UV and gradient RP-HPLC method can be successfully applied for the routine quality control analysis in pharmaceutical dosage forms.