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Asian Journal of Pharmacy and Technology
Year : 2019, Volume : 9, Issue : 3
First page : ( 179) Last page : ( 184)
Print ISSN : 2231-5705. Online ISSN : 2231-5713.
Article DOI : 10.5958/2231-5713.2019.00030.8

Development and Validation of HPLC Method for Estimation of Pharmaceutical Drug and its Stability Studies in Simulated Biological Fluid: Comparative Study

Patil Sushil D.*, Dugaje Tejashri, Dr. Kshirsagar Sanjay J.

MET's Institute of Pharmacy, MET League of Colleges, Bhujbal Knowledge City, Adgaon, Nashik, Savitribai Phule Pune University, Maharashtra, India

*Corresponding Author E-mail: sushilpharma@rediffmail.com

Online published on 31 December, 2019.

Abstract

A simple and precise high performance liquid chromatography method for determination of candesartan cilexetil in their pharmaceutical formulation was developed and validated. The separation was carried out on Cosmosil C18 (250mm X 4.6, 5μ) RP-HPLC column using an 0.8ml/min as flow rate with methanol: water (80: 20 v/v) mobile phase. Quantification was performed with a UV detector at 214nm, solubility and stability was determined individually in simulated biological fluids at various pH was investigated. The calibration curves of candesartan cilexetil were linear in the range of 10–50 μg/ml (R²=0.999). The developed method was applied to pharmaceutical formulation successfully with no interfering peaks. The percentage recovery was 99.71–100.29%. It was observed that solubility of candesartan cilexetil was increased in all invitro medium, in 1.2 and slightly 7.4 pH and the stability of candesartan cilexetil was stable in pH 1.2 or degraded in pH 7.4 for 24 hours.

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Keywords

Candesartan cilexetil, RP-HPLC method, Validation, Simulated biological fluids, stability study.

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