Development of Analytical Methods for the Estimation of Torsemide and Spironolactone in Tablet Dosage Form.

The present study aims to develop simple, precise and accurate methods for the determination of Torsemide and Spironolactone by simple UV methods and RP-HPLC method in bulk and in formulation. The extensive survey of literature for Torsemide and Spironolactone regarding their physio chemical properties, pharmacological properties and analytical methods. This formed the basis for the development of methods. Identification, selection and collection of Torsemide and Spironolactone for analysis. Selection of suitable solvent for quantitative extraction of drug present in the formulations. The solvent should be readily available, economical and of analytical grade for UV-spectroscopy and HPLC grade for RP-HPLC and should not chemically interact with the compound of interest and its structural characteristics. Selection of suitable method for analysis depending upon the spectral characteristics of the drug. Selection of suitable wavelength for rapid and accurate simple UV spectroscopic methods development. Development of rapid and accurate RP-HPLC method by using UV detector, Analysis of marketed tablet formulation by the proposed methods. Statistical analysis of developed analytical methods. Validation of analytical methods as per the ICH guidelines. Torsemide is a pyridine-sulfonylurea type loop Diuretic mainly used in the management of oedema associated with Congestive Heart Failure. It is also used at low doses for the management of hypertension. Spironolactone is a powerful aldosterone antagonist. The proposed analytical methods are simple, economical, rapid, sensitive, reproducible and accurate for the estimation of Torsemide and pironolactone. The methods adopted for studies were UV- spectroscopic method for the estimation of Torsemide and Spironolactone in combined dosage form by Simultaneous equation method, Absorbance ratio method, Derivative spectroscopic metho UV-spectroscopic method for the estimation of Torsemide in different formulations RP-HPLC method for the estimation of Torsemide and Spironolactone in combined dosage form. The drug samples containing Torsemide and Spironolactone in combined dosage form were analyzed by UV-spectroscopic method using methanol followed by 0.02 M Phosphate buffer (pH-3.5) as a solvent and the content of drug present in each formulations (Torlactone and Dytor+) were found to be satisfactory. The estimation of Torsemide containing tablets by UV-spectroscopic method using 0.1N HCl was done and four formulations were selected [Torsinex 10 mg, Henletor 20 mg, Tide 10 mg and Dytor 10 mg]. The results were found to be satisfactory. Simultaneously, a newer RP-HPLC method has been developed for the estimation of both drugs in bulk and in formulation. The proposed method gives reliable assay results with short analysis time using mobile phase phosphate buffer (pH 3.5): Methanol: Acetonitrile in the ratio of 40:30:30 respectively. The content of drug present in the formulation (DYTOR+) was found to be satisfactory and system suitability parameters are in desired limit, all the above methods do not suffer from any interference due to common excipients. It indicates that the methods were accurate. Therefore the proposed methods could be successfully applied to estimate commercial pharmaceutical products containing Torsemide and Spironolactone.