APPLICATION OF A VALIDATED STABILITY-INDICATING HPTLC METHOD FOR SIMULTANEOUS QUANTITATIVE DETERMINATION OF CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE IN PHARMACEUTICAL DOSAGE FORM
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 5
Abstract
Objective: To develop and validate stability indicating HPTLC method for simultaneous quantitative determination of candesartan cilexetil (CDT) and hydrochlorothiazide (HCT) in pharmaceutical dosage form.Methods: The present study deals with development and validation of stability indicating HPTLC method for simultaneous estimation of CDT and HCT. Chromatographic separation was performed on aluminum plate precoated with Silica Gel 60 F254 using toluene: chloroform: ethanol: glacial acetic acid (2:7:1:0.1 v/v) as mobile phase. The wavelength selected for densitometry scanning was 270 nm. Regression plots revealed linear relationships in the concentration range of 500-5000 and 400-2000 ng/band for CDT and HCT respectively. The correlation coefficient of calibration curves was found to be more than 0.99 for both analytes.Results: The chromatographic conditions gave compact spots at Rf value (±SD) 0.12 (±0.01) and 0.70 (±0.02) for HCT and CDT respectively. The method was validated as per International Conference on Harmonization (ICH) guidelines, demonstrating to be accurate and precise within the corresponding linearity range of titled analytes. Inherent stability of these drugs was studied by exposing drug substances to various stress conditions as per ICH guidelines namely oxidative, photolysis and hydrolytic conditions under different pH. Relevant degradation was found to take place under these conditions.Conclusion: A new simple, accurate, precise, sensitive and economic stability-indicating HPTLC method has been developed and validated for the simultaneous determination of CDT and HCT in pharmaceutical dosage form. The proposed method can be used for the routine estimation of CDT and HCT in bulk and formulation and can be employed for stability-indicating analysis.Keywords: Candesartan cilexetil, Hydrochlorothiazide, HPTLC, Stability indicating method, Forced degradation, Stress studies, Validation
Authors and Affiliations
Ambekar A. M. , Kuchekar B. S.
Keywords
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