ABSTRACT:
A simple, rapid, sensitive and accurate isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous determination of Spirinolactone and Hydrochlorthiazide in combined dosage form. The method was employed on a µ-Bondapak C18 column (150 mm × 4.6 mm, 5 µm) at ambient temperature. The mobile phase consisted of methanol: 0.02M dibasic sodium phosphate containing Trifluroacetic acid and (40:60, pH 3.2) at a flow rate of 1 ml/min. The UV detection wavelength was set at 278 nm and 20 µL of sample was injected into the HPLC system. The developed method was validated as per ICH guidelines with respect to specificity, linearity, precision, accuracy, robustness and limit of quantification. The suggested method was successfully applied for the simultaneous analysis of the studied drugs in their co-formulated tablets. The results of analysis were subjected to statistical analysis.