Development, Validation, and Forced Degradation Studies of a Stability-Indicating RP-HPLC Method for Ranolazine in Bulk Drug and Tablets

Abstract

Forced degradation is a degradation of new drug substance and drug product at conditions more severe than accelerated conditions. It is required to demonstrate specificity of stability indicating methods and also provides an insight into degradation pathways and degradation products of the drug substance and helps in elucidation of the structure of the degradation products. Estimation of Ranolazine was achieved by using UV visible spectrophotometer (SHIMADZU 1800). The normal spectrum of Ranolazine was recorded using the solvent methanol and distilled water. Then the zero order spectra of Ranolazine was recorded, showed maximum absorbance at 274nm. Methanol was selected as solvent. The linearity and range were found to be in the range of 10-60 mcg/ml. The correlation coefficient of Ranolazine at 274nm in bulk was found to be 0.999, showed good linearity between above range. For HPLC study; the mobile phase Acetonitrile: Methanol: Water (50:30:20%v/v) was selected. Run time was selected to be 10.0 min because analyze gave peak around 5.462±0.02 min respectively and also to reduce the total run time. The percent recovery was found to be 98-102%   was linear and precise over the same range. The sample exposed to condition like hydrolytic and oxidative degradation in 20% H₂O₂. The reaction was carried out at room temperature for 30 min at 60^oc. UV chamber was used for photo degradation studies. The analytical method as developed by studying different parameters. Simple, precise and accurate method was developed for the estimation of Ranolazine.