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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 5
First page : ( 2376) Last page : ( 2380)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00427.8

Development and Validation of a Stability indicating RP-HPLC Method for the Estimation of Chlorthalidone and Cilnidipine in Combined Pharmaceutical Dosage Form

Sawaikar Leena1,2,*, Kapupara Pankaj3

1PES's Rajaram and Tarabai Bandekar College of Pharmacy, Farmagudi-Ponda, Goa

2Research Scholar, R K University, Bhavnagar Highway, Kasturbadham, Rajkot-360020, Gujarat, India

3School of Pharmacy, R K University, Bhavnagar Highway, Kasturbadham, Rajkot-360020, Gujarat, India

*Corresponding Author E-mail: sawaikarleena@gmail.com

Online published on 16 June, 2020.

Abstract

A simple and a rapid stability indicating RP-HPLC method has been developed for the estimation of Chlorthalidone and Cilnidipine in their combined dosage form. The separation was achieved on waters C18 column, (100mm x 4.6mm, 2.5μm) using a mobile phase consisting of phase A, (0.1%Formic acid in methanol: Acetonitrile in the ratio 80: 20 v/v) phase B, (10 mM ammonium acetate) in gradient mode, at aflow rate of 1.0mL/min. The wavelength selected for detection was 240 nm and a PDA detector was employed for the detection. The retention time of Chlorthalidone was 6.047±0.2 min and Cilnidipine was 12.642 ±0.2 min. The developed method was validated for specificity, linearity, accuracy precision and robustness. There was no interference seen in the blank at the retention time of the drugs hence the method was specific. The linear regression seen in calibration curve of both the drugs was 0.999. The mean percent recovery of Chlorthalidone and Cilnidipine was within the acceptance criteria. Both the drugs were subjected to a variety of stress environment which included acid, base, peroxide, UV radiations and heat. It was observed that the peaks of the degradants of both the drugs could be well resolved from that of pure drugs. The proposed method can be used for rapid quantification and simultaneous analysis of both drugs from commercial formulations without any interference.

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Keywords

Chlorthalidone, Cilnidipine, RP-HPLC, Validation.

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