Development and Validation of UV Spectrophotometric Method of Pirenzepine Dihydrochloride in API and Stress Degradation Studies

A simple, accurate, precise spectrophotometric method was developed for the detection of Pirenzepine dihydrochloride (PZC). The optimum condition for the analysis of the drug was studied. PZC was subjected to stress degradation under different conditions like acidic, alkali, neutral, oxidation, photolytic, and thermal degradation as per recommended by the International Conference on Harmonization (ICH). The samples thus prepared were used for degradation studies by with the developed method. The lambda max i.e. absorption maxima found at 281nm and calibration curve linear over the range of 0-20µg/ml. The standard regression equation and correlation coefficient fond to be y = 0.04x + 0.056 R² = 0.998 respectively. Percent RSD found to be less than one. The accepted limits of accuracy (recovery) were found to be 90% - 120% and all observed data are within required range which indicates good recovery value. and LOD and LOQ found to be 0.165 and 0.500 respectively by simple UV spectroscopy.