Analytical Method Validation of Simultaneous Determination of Spironolactone and Furosemide in Tablet Formulation and its Statistical Evaluation

The objective of current study was to Statistical Comparison for Precision and Intermediate Precision study for Analytical Method Validation of Spironolactone and Furosemide in tablet formulation and developed easy, exact and correct isocratic stability indicating reversed phase HPLC assay method and validated for determination of Spironolactone and Furosemide in solid pharmaceutical dosage forms. Isocratic RP-HPLC separation was achieved on an SGE make 150 4.6mm SS Wakosil II 5C18RS 5 μm column (Part Number: 206610 and Serial Number: A01-063) using mobile phase of Acetonitrile- Ammonium acetate buffer (50:50, v/v) at a flow rate of 1.1 ml/min and the detection was carried out at 254 nm using photo-diode array detector. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 40-160 µg/ml with a correlation coefficient 0.9977 and 0.9953 for Spironolactone and Furosemide respectively. The precision (RSD) amongst six-sample preparation was 0.87% and 1.1 % for Spironolactone and Furosemide respectively. For repeatability and intermediate precision (RSD) amongst six-sample preparation was 0.46 % and 0.20 % for Spironolactone and Furosemide respectively. As result shown that for furosemide, % RSD was 1.12% and in ANOVA study Significance F value found 0.625502408 and for spironolactone Precision study and Intermediate precision study % RSD was 0.68, in ANOVA study Significance F value found 0.905843808.