METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS DETERMINATION OF HYDROCHLOROTHIAZIDE AND LOSARTAN IN TABLET DOSAGE FORM BY RP-HPLC

Fixed-dose combinations have several advantages comparing with a single drug and separate agents. For simple dosing regimens and their synergistic antihypertensive action, a combination of hydrochlorothiazide and losartan potassium is widely prescribed. In this study, an HPLC-UV method was developed and validated for the simultaneous determination of hydrochlorothiazide and losartan in bulk and pharmaceutical formulation. The method was optimized selecting chromatographic conditions of 60: 40 acetonitrile: water, ACE3-C18 column (250 mm x 4.6 mm 5 mu m), 20 mu l injection volume, the flow rate of 1 ml/min at ambient temperature (25 degrees C), and 226 nm. The method was validated giving good precision (RSD% < 1), acceptable linearity (R2 >= 0.997), and low LOD and LOQ (0.5 and 1.5 mu g/ml, respectively). Successful application on pharmaceutical dosage tablet form gave recovery percent within acceptance criteria (92% and above) indicating that the proposed method is simple and reliable for the determination of LOP and HCTZ and hence can be applied for routine analysis in quality control laboratories.