Analytical Method Development and Validation of Hydrochlorothiazide and Eposartan in API and its Dosage form by RP-HPLC

R. Narsimha Rao¹, N. Karnakar² J. Sushma³, P. Amani^4
1,2,3,4Venkateshwara Institute of Pharmaceutical Sciences, Charlapally, Nalgonda, Telangana.

A B S T R A C T
On the basis of experimental results, the proposed method is suitable for the quantitative determination of Hydrochlorothiazide and Eposartan in pharmaceutical dosage form. The method provides great sensitivity, adequate linearity and repeatability. The estimation of Hydrochlorothiazide and Eposartan was done by RP-HPLC. The Phosphate buffer was pH 4.6 and the mobile phase was optimized which consists of MEOH: Phosphate buffer mixed in the ratio of 70:30 % v/ v. A Symmetry C18 (4.6x 150mm, 5mm, Make XTerra) column used as stationary phase. The detection was carried out using UV detector at 273 nm. The solutions were chromatographed at a constant flow rate of 1.0 ml/min. the linearity range of Hydrochlorothiazide and Eposartan were found to be from 25-125 mg/ml. Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-102% of Hydrochlorothiazide and Eposartan LOD and LOQ was found to be within limit. The proposed method is precise, simple and accurate to determine the amount of Hydrochlorothiazide and Eposartan in formulation. High percentage of recovery shows that the method is free from the interference of excipients used in the formulation. So the method can be useful in the routine quality control of these drugs.
Keywords: Symmetry C18, Hydrochlorothiazide and Eposartan RP-HPLC