Research Article
Patel, C.M., Chaudhari, B.G.
The degradation behavior of Ropinirole Hydrochloride (ROPI) , under various stress conditions of acid/base hydrolysis and oxidation using Spectrophotometry. Stability indicating spectrophotometric method was developed that could separate the drug from its degradation products formed under these stressed conditions. The UV spectral characteristics of the drug and degraded products were quite different and first-order derivative UV spectrophotometric method was used to study the extent of degradation. ROPI was found to degrade extensively under experimental conditions. The method was validated the linearity, precision, accuracy, and specificity. The described method was found to be linear over the range of 5-50 µg mL-1 for ROPI. The mean recovery was found to be 99.03±1.11, %. The intermediate precision data were obtained under different experimental conditionsfirst-orderand the calculated value of the coefficient of variation (CV, %) was found to be less than a critical value. The proposed method can be successfully useful to determine the degradation of a drug during storage.
Stress conditions, Stability-indicating, Spectrophotometry, Ropinirole Hydrochloride
INTRODUCTION
The need to develop a stability indicating method using stress degradation has been recommended by International Conference on Harmonization (ICH)1. The stress conditions should include the effect of temperature, humidity, light, acid/base hydrolysis and oxidation. The aim of the current study was to study the degradation behavior of ropinirole hydrochloride (ROPI) under few ICH prescribed conditions and to develop validated stability indicating spectrophotometric assay method.
