DEVELOPMENT AND VALIDATION OF NOVEL UV AND RP-HPLC METHODS FOR DETERMINATION OF CILNIDIPINE (A NEW GENERATION Ca CHANNEL BLOCKER) IN PHARMACEUTICAL DOSAGE FORMAbstract
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 λmax 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.
P. R. Sankar *, V. Swathi and P. S. Babu
Department of Pharmaceutical Analysis and Quality Assurance, Vignan Pharmacy College, Vadlamudi, Andhra Pradesh, India.
17 July 2018
26 October 2018
30 October 2018
01 April 2019