Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING GRADIENT RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND CHLORTHALIDONE IN BULK API AND FIXED DOSE COMBINATION

Bhamini R. Chaudhary* and Dr. Jayant B. Dave

Abstract

Telmisartan and Chlorthalidone is an approved widely used antihypertensive fixed dose combination of angiotensin receptor blocker and diuretic drugs. The main objective was to develop a stability indicating RP-HPLC Method for simultaneous estimation of both the drugs in bulk API and Fixed Dose Combination. In RP-HPLC method, separation was achieved by Agilent Extend C18 (150 mm× 4.6 mm id, 5 μm particle size) column using Disodium Hydrogen Phosphate Buffer of pH-6.5: Acetonitrile in Gradient run with starting ratio of 75:25, % v/v as the mobile phase with detection wavelength of 235 nm. The retention time of Chlorthalidone and Telmisartan were found 3.82 min and 14.23 min respectively. The linearity was found to be in range of 6-18 mcg/mL and 20-60 mcg/mL respectively. The percent Recovery of Chlorthalidone and Telmisartan was found to be in the range of 99.19-101.19 % and 99.19- 101.91% respectively. The developed method adequately separate potential degradation products formed under stress conditions establishing specificity of the method for the estimation of the drugs. Chlorthalidone degraded significantly under acidic and alkaline conditions and marginally under oxidative, photolytic and neutral conditions while it was stable under thermal condition. Telmisartan degraded significantly under neutral degradation conditions, marginally under acidic, alkaline and thermal conditions and remained stable under oxidative and Photolytic condition. The proposed method was validated as per ICH Guidelines thus it can be successfully applied for the estimation of drugs in Telmisartan and Chlorthalidone Tablets.

Keywords: Telmisartan (TEL), Chlorthalidone (CHLO), RP-HPLC, Stability Indicating Assay Method, Validation, ICH- Guidelines.