Development and Validation of Ultraviolet and Reverse Phase-high Performance Liquid Chromatographic Method for Estimation of Cilnidipine
Biswajit Samantaray
School of Pharmacy and Life Sciences, Centurion University of Technology and Management, Odisha, India.
Jagannath Panda
School of Pharmaceutical Sciences, Siksha ‘O’ Anusandhan University, Odisha, India.
Satyapriya Mahapatra
Royal College of Pharmacy and Health Sciences, Odisha, India.
Kajal Ray
Royal College of Pharmacy and Health Sciences, Odisha, India.
Satish Kanhar
School of Pharmacy and Life Sciences, Centurion University of Technology and Management, Odisha, India.
*Author to whom correspondence should be addressed.
Abstract
Aim: The current experiment was to develop and validate a straight forward RP-HPLC methodology for the determination of Cilnidipine.
Methodology: UV spectroscopy was used to estimate Cilnidipine. Action separation of Cilnidipine was achieved by employing a C18 column. Mobile phase combination of methanol: water (90:10 v/v) was tense at the flow of 1 ml/min. Detection was performed at 241 nm. Validation parameters were evaluated in line with the International conference on harmonization (ICH) Q2R1 guidelines.
Results: The standardization curve was linear within the varying concentration of 2-10 mg/ml for Cilnidipine with parametric statistic (r2) equal to 0.999. The tactic was found to be accurate (101.66% recovery), precise (intraday, 1.65 and inter day, 1.38) and robust (% RSD was calculated to be 0.66, 0.58 and 0.81 for variation in mobile phase composition, wave length and flow velocity respectively) for the analysis of Cilnidipine.
Conclusion: The developed method has passed all the validation tests and can be successfully applied to estimate the presence of Cilnidipine in bulk as well as in pharmaceutical formulations.
Keywords: UV spectroscopy, RP-HPLC, Cilnidipine, hypertension, linearity, precision