Development and Validation of RP-HPLC Method for the Determination of Hydrochlorothiazide in Bulk Drug and Pharmaceutical Dosage Form

Abstract

An HPLC-PDA method was developed and validated for the determination of hydrochlorothiazide in bulk and pharmaceutical formulation. The method was optimized selecting chromatographic conditions of 50 : 50 acetonitrile : water, Inertsil® column (ODS-3 250 mm × 4.6 mm 5 μ m), 20 μ L injection volume, flow rate of 1 mL/min at ambient temperature (30°C), and 272 nm. Another column of C 18 Zorbax® (Eclipse Plus, 4.6 × 250 mm, 5 μ m) was tested showing no big difference in the method results. The method was validated giving good precision (RSD% < 1), acceptable linearity ( R 2 ≥ 0.9978), and low LOD and LOQ (0.5 and 1.7 μ g/mL, resp.) on both columns. Successful application on pharmaceutical dosage tablet form gave high recovery of 99.93%. The method was compared with official BP and other reported methods. The proposed method is economic, simple, and rapid and hence can be employed for routine analysis in quality control laboratories.