European Journal of Biomedical and Pharmaceutical Sciences

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF HYDROCHLOROTHIAZIDE IN TABLET FORMULATION BY USING RP-HPLC

Anamika Gupta* Chandana Majee, Salahuddin and Richa Jindal

ABSTRACT

A reverse phase High Performance Liquid Chromatographic method was developed and validated for the quantitation of an Anti-Hypertensive drug Hydrochlorothiazide in bulk and pharmaceutical dosage form. The analysis was performed on Waters SUN FIRE C18 column (4.6mm x 50, 5μm) with a mobile phase composed of tri fluoro acetic acid (0.1%, acidic) and acetonitrile in gradient mode at a flow rate of 1.0 ml/min with detection of analyte at 225nm. The separation was achieved within 3.07min. The method validation parameters showed good results for linearity, accuracy, and precision. The calibration curve was linear in the concentration range 25-150 μg/ml with coefficient of correlation 0.999. The mean recovery was found to be 98.20%. The LOD and LOQ were found to be 3.07 μg/ml and 9.33 μg/ml. The proposed method was validated as per ICH guidelines for various parameters like accuracy, precision, linearity and robustness.

Keywords: Hydrochlorothiazide (HCTZ), RP-Hplc, TRI Fluoro Acetic Acid Buffer (2.3 PH), Acetonitrile.