DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD FOR IPRATROPIUM BROMIDE BY USING RP-HPLC

A simple stability indicating RP-HPLC method was validated for determination of ipratropium bromide in the bulk drug. The drug was resolved using HPLC Column (Kromasil ODS 150 x 4.6 mm C18 column) with mobile phase of HPLC grade acetonitrile:potassium di-hydrogen phosphate buffer (60:40 v/v) at a flow rate of 1 ml/min. The retention time of ipratropium bromide was 3.7 min with UV detection at 254 nm. The method was validated with respect to linearity, sensitivity, accuracy, precision and robustness as per the International Conference on Harmonization (ICH) guidelines. The method was specific and it was observed that no interference with diluents. The linearity was established over the concentration range of 20-120 μg/ml with correlation coefficients (r2) 0.9958 for ipratropium bromide. The mean recovery was found to be in the range of 99.8% for ipratropium bromide. The % R.S.D. values for intraday precision study and inter-day study were <1.0%, confirming that the method was sufficiently precise. The drug was subjected to forced degradation under different conditions. The drug was degraded more in oxidative condition (28.89%) then alkaline condition (26.39%) then acidic condition (13.42%). There was no degradation seen under the thermal conditions.