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Abstract

DEVELOPMENT OF NEW LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF HYDROCHLOROTHIAZIDE AND CANDESARTAN CILEXETIL AND ITS APPLICATION IN SOLUBILITY ENHANCEMENT STUDIES

Y Padmavathi*, N.Raghavendra Babu, P Ravi kumar, Sheryl Andrews

Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy, Mehdipatnam,
Hyderabad, Telangana-28.

ABSTRACT

A liquid chromatographic method was developed for the estimation of hydrochlorothiazide (HCT) and candesartan cilexetil (CSC) in solid dispersions as a part of solubility enhancement studies. In this method drugs were resolved by using C18 column and mobile phase consisting of phosphate buffer pH 5 and acetonitrile (30:70 %v/v). The mobile phase was pumped at a flow rate of 1 mL/min and UVdetection was carried out at 255 nm. The quantification of drugs was achieved by using external standard method. The method was validated as per ICH Q2 (R1) guidelines. Linearity was observed over concentration range of 2-10 μg/mL and the coefficient of determination was found to be 0.99. The limit of detection and limit of quantitation were found to be 1.31 μg/ml and 3.97μg/mL for hydrochlorothiazide and 1.72μg/ml and 4.39μg/mL for candesartan cilexetil. The liquid chromatographic method was proved to be acuurate and precise. The validated method was successively applied to study the enhanced solubility of both drugs in the prepared solid dispersions.

Keywords: Hydrochlorothiazide, Candesartan cilexetil, Solid dispersion, Limit of detection, ICH guidelines.


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