Validated HPTLC technique for simultaneous estimation of candesertan celexitil and hydrochlorothiazide in pharmaceutical dosage form

Abstract

Aim: Analytical HPTLC technique was developed for the simultaneous estimation of candesertan celexitil (CAN) and hydrochlorothiazide (HYD) in 2 totally different strengths of pharmaceutical dosage form. Materials and Methods: Chromatography was performed on 60F 254 TLC pre-coated aluminum plates with mobile phase of toluene: ethyl acetate: formic acid (85%) in the ratio of 6:4:1 v/v. The mean Rf values with standard deviation were found to be 0.39 ± 0.01 and 0.73 ± 0.01 for CAN and HYD, respectively. Results: The linear regression data has shown a good linear relationship over a concentration range of 200-1200 ng/spot for each drug with a correlation coefficient of 0.9999. Limit of quantification and the limit of detection establish the sensitivity of the developed technique. The stability study indicates that drugs were stable up to 72 hours. The technique was precise and relative standard deviations were found to be less than 0.05%. System suitability tests are used to verify that the resolution and repeatability of the system is adequate for the analysis. The technique was specific and selective since there is no additional peak beside with main peak. The Robustness study, recovery study and percentage of assay of the formulation were within the limit as per ICH guidelines. Conclusion: A simple, rapid, cost-effective, eco-friendly, specific, precise, sensitive and efficient analytical HPTLC technique was developed for the simultaneous estimation of candesertan celexitil (CAN) and hydrochlorothiazide (HYD) completely in 2 totally different strength of pharmaceutical marketed formulations.