Development and Validation of Stability Indicating RP-HPLC method for estimation of drug used in Congestive Cardiac failure in I.V. dosage form

Abstract

A new, simple, precise, rapid, selective and stability indicating Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for drug D7552 used in treatment of congestive cardiac failure in I.V. dosage form. The method is based on reverse phase chromatography using Hypersil BDS C-18 (100×4.6 mm) 3.5μ particle size column. The separation of peak of the drug and all degradation peaks was achieved by using isocratic mobile phase of mixture of 0.05% TEA : Methanol (55:45 v/v) (pH-4) at a flow rate of 1.0 mL/min and UV detection at 285 nm. Stability indicating capability is established by forced degradation experiment of Drug D7552 with acid, alkali, oxidation and thermal degradation conditions. The peak of the Drug D7552 was found to be of acceptable peak purity index without any interference. Also the peaks of degraded products were well resolved. The linear regression analysis data for the calibration plots showed good linear relationship with concentration range of 25 - 75 μg/mL and correlation coefficient was found to be 0.9999. Mean % Assay of I.V. dosage form was found 100.1 %. The method was validated for specificity, accuracy, precision, linearity, repeatability and robustness as per ICH Q2(R1) guidelines. All the results of above mentioned parameters were found to be within the acceptance criteria, indicate that the method can be apply for routine analysis in quality control laboratories.