A REVIEW: METHOD DEVELOPMENT AND VALIDATION OF RELATED SUBSTANCES BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY ACCORDING TO ICH GUIDELINES

This present review addresses briefly about a simple, sensitive and reproducible Reverse phase High performance liquid chromatography (HPLC) coupled with a photodiode array detector, method applicable for the quantitative determination of related substances in API . The drug must be subject to the International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic and thermal stress conditions. The performance of the method should be validated according to the present ICH guidelines for specificity, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness and robustness.