Balakrishna et al Journal of Drug Delivery & Therapeutics. 2020; 10(1):97-100 ISSN: 2250-1177 [97] CODEN (USA): JDDTAO Available online on 15.01.2020 at http://jddtonline.info Journal of Drug Delivery and Therapeutics Open Access to Pharmaceutical and Medical Research © 2011-18, publisher and licensee JDDT, This is an Open Access article which permits unrestricted non-commercial use, provided the original work is properly cited Open Access Research Article Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine Tiwari Balakrishna 1* , Shirsat Mrunal K. 2 , Kulkarni Amol 3 1 Research Scholar, Pacific University, Udaipur, India 2 Dean/Principal, PAHER University, Udaipur, India 3 Director, Institute of Pharmaceutical Science and Research (for girls), Swami Chincholi, Daund, Maharashtra, India ABSTRACT Cilnidipine is one of the dihydropyridine calcium antagonists. It was created combinedly by Fuji Viscera Pharmaceutical Company, Ajinomoto and Japan and was approved in the year 1995. Cilnidipine acts on N-type calcium channel where exist the end of sympathetic nerve in addition to common L-type calcium channel like that of other calcium antagonists. China, Japan, India, Korea and several other countries approved this drug. The objective of the method validation is to demonstrate whether the method was suited for the intended purpose. The method was validated as per the ICH guidelines. The method was validated for linearity, precision (repeatability, intermediate precision), accuracy, specificity, robustness, limit of detection and limit of quantification. Cosmosil (4.6 X 250mm, 5 μ) column was used for separation. The selected wavelength for Cilnidipine was 241 nm. The mobile phase consists Methanol: Potassium dihydrogen phosphate buffer (50:50). Flow rate was delivered at 1.0 mL/min. Appropriate dilutions of standard stock solutions were prepared as per the get desired concentrations in the range of 100-500 mcg/ml. The RT obtained was 4.8165 minutes. Keywords: Cilnidipine, UV spectroscopy, RP-HPLC, ICH Article Info: Received 10 Nov 2019; Review Completed 25 Dec 2019; Accepted 04 Jan 2019; Available online 15 Jan 2020 Cite this article as: Tiwari B, Shirsat M K, Kulkarni A, Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine, Journal of Drug Delivery and Therapeutics. 2020; 10(1):97-100 http://dx.doi.org/10.22270/jddt.v10i1.3846 *Address for Correspondence: Tiwari Balakrishna, Research Scholar, Pacific University, Udaipur, India INTRODUCTION: Cilnidipine is one of the dihydropyridine calcium antagonists. It was created combinedly by Fuji Viscera Pharmaceutical Company, Ajinomoto and Japan and was approved in the year 1995. Cilnidipine acts on N-type calcium channel where exist the end of sympathetic nerve in addition to common L-type calcium channel like that of other calcium antagonists. China, Japan, India, Korea and several other countries approved this drug. 1 IUPAC nomenclature: 3-(2-methoxyethyl) 5-(2E)-3- phenylprop-2-en-1-yl 2,6-dimethyl-4-(3-nitrophenyl)-1,4- dihydropyridine-3,5-dicarboxylate Literature review suggest few RP-HPLC, HPTLC, spectroscopic, stability indicating HPLC determinations were performed. 2-15 The aim of the present study is to develop a simple, precise, accurate, sensitive HPLC method for the determination. After, doing in depth study in the present research work, it was found that the present research work is having various advantages over the previous work. The advantages include less retention times of the component, with good resolution. The % RSD of robustness was found to be less. The results obtained from the validation suggest that the method was found to be precise, accurate, linear and robust enough and the method was also found to be economical. Figure 1: Structure of Cilnidipine