Analytical method development and validation ofsimultaneous estimation of hydrochlorothiazideand triamterene in combined tablet dosage form byRP-HPLC

Abstract

A new simple, accurate, rapid and precise isocratic high performance liquid chromatographic method was developed and validated for the determination of Hydrochlorothiazide (HTZ), and Triamterene (TMT) in tablet formulation. The optimized conditions comprises of column Symmetry C18 250 mm × 4.6 mm I.D; 5 μm with a flow rate of 1.0 mL/min, 0.05 M Phosphate buffer, methanol and acetonitrile mixture was used as mobile phase in the ratio 55:35:10 v/v at a detection wavelength 270 nm. Retention times of HTZ and TMT were found to be 3.49 min, and 4.68 min with a tailing factor 1.25, 1.27 and 4704, 4841 as theoretical plates respectively which are within the limits. All the parameters were validated according to the ICH guidelines and found to be within limits. The LOD values of HTZ and TMT were found to be 0.089 and 0.251 µg/mL respectively. HTZ and TMT LOQ’s were found to be 0.27, and 0.78µg/mL respectively. Linearity ranges for HTZ, and TMT were 2-10 µg/mL, and 3-15 µg/mL respectively. Percent recovery study values of HTZ and TMT were found to be within 98-102%.