UV SPECTROPHOTOMETRIC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CLOMIPHENE CITRATE IN METHANOL

The present study describes simple, accurate, precise and cost effective UV-spectroscopic method for the estimation of clomiphene citrate in methanol as per ICH guidelines. The absorption maxima for clomiphene citrate in methanol was found to be 235nm and 294 nm. The drug follows linearity (linearity 1, linearity 2 & linearity 3) in the concentration range 3-40 mu g/ml at 294 nm and 3-24 mu g/ml at 235 nm with a correlation coefficient value of 0.9991, 0.9989, 0.9988 and 0.999, 0.9994, 0.9994 respectively. The accuracy of the method was checked by recovery experiment performed at three levels i.e., 80%, 100%, 120%. The percent recovery was found to be in the range of 90-120%. The low values of % RSD are indicative of accuracy and reproducibility of method. The % RSD <2 indicates that method is precise. The ruggedness of method was studied with the help of different analysts. No significant degradation of clomiphene citrate was showed in force degradation studies like heat-induced degradation the spectra for acid degradation, acid/base hydrolysis, oxidation and photo degradation. The above method was a rapid tool for estimation of clomiphene citrate in formulations.