Validated Rp-Hplc Method For Simultaneous Estimation Of Torsemide And Spironolactone In Bulk And Tablet Dosage Form.

Abstract

Background: A simple, accurate and precise HPLC method for simultaneous determination of Spironolactone and Torsemide in pure and tablet dosage form has been developed. Aim: To develop and validate analytical method for simultaneous estimation of Spironolactone and Torsemide in pharmaceutical formulation by RP-HPLC.

Materials and Methods: HPLC of Waters (Model: Alliance 2695) with Phenomenex Luna C18 (4.6 mm I.D. × 250 mm, 5 µm) column was used for chromatographic separation. It contains waters injector and PDA Detector (Deuterium). Mobile phase consists of Methanol:Water (65:35% v/v) and flow rate adjusted was 1ml/min. Wavelength selected for detection was 220nm and injection volume was 10 µl. Results and discussion: By using the developed method, retention time of Spironolactone and Torsemide was found to be 3.2min and 5.4min respectively. The method has been validated for  linearity,  accuracy  and  precision.  Linearity of Spironolactone and Torsemide were in the range of 75–375μg/ml and 15–75μg/ml respectively. The percentage recoveries obtained for Spironolactone and Torsemide were found to be in range of 99.3 – 99.6%. LOD and LOQ were found to be 12.5µg/ml and 38.1µg/ml for Spironolactone 3.7and 11.4µg/ml for Torsemide. Conclusion: The developed HPLC method offers several advantages  such  as  rapidity, usage of simple mobile phase and easy sample preparation steps. Further, improved sensitivity makes it specific and reliable for its intended use. Hence, this method can be applied for the analysis of pure drug and pharmaceutical dosage forms.  From the present study it can be concluded that the proposed method is simple, sensitive,    precise,    specific,    accurate    and    reproducible. Results  of validation parameters  demonstrated  that  the  analytical  procedure  is  suitable  for  its  intended purpose and meets the criteria defined in ICH Q2R1.