New Analytical Method Development And Validation For The Simultaneous Estimation Of Telmisartan And Hydrochlorothiazide In Bulk And Tablet Dosage Form Using RP-HPLC

Abstract

A simple, sensitive, precise and specific reverse phase high performance liquid Chromatographic method was developed and validated for the determination of Telmisartan and Hydrochlorothiazide in combined tablet dosage form. The method was validated as per ICH guidelines. The separation was carried out by using a mobile phase consisting of methanol: acetonitrile: water in the ratio (40:40:20%v/v). The column used was Zodiac C18, 250 × 4.5 mm with flow rate of 1.0ml/min using UV detection at 270 nm. The described method was linear over a concentration range of 40-280µg/ml and 12.5-87.5µg/ml for Telmisartan and Hydrochlorothiazide respectively. The retention times of Telmisartan and Hydrochlorothiazide were found to be 4.63 and 6.14 min respectively. Results of analysis were validated statistically and by recovery studies (recovery range of Telmisartan was found to be 98.19- 101.32% and for Hydrochlorothiazide it was obtained as 98.67-100.99%. The limit of detection (LOD) of Telmisartan was found to be 0.75μg/ml and for
Hydrochlorothiazide it was 2.5μg/ml. The limit of quantification (LOQ) for Telmisartan and Hydrochlorothiazide were found to be 2.5μg/ml and 8.25μg/ml respectively. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Telmisartan and Hydrochlorothiazide in its pharmaceutical dosage form.