Method Development and Forced Degradation for SUN ® Peptide Using RP-HPLC

Abstract

This study provides an overview on the method development of SUN® Peptide API and forced degradation study on SUN® Peptide API with the Reversed phase high performance liquid chromatography. Different stress conditions (hydrolysis, thermal and oxidation) were applied to SUN® Peptide API drug this process is known as forced degradation, as a result various degradation products are created. The method was validated according to ICH guideline with respect to linearity, robustness, Limit of Detection, Limit of Quantification, solution stability and system suitability. The forced degradation was also validated according to the International Conference on Harmonization (ICH). For this, the gradient programming is used with buffer, acetonitrile and methanol at a flow rate of 0.7ml/minute over RP C18 X-select CSH – C18 (150x4.6) mm 2.5 μ column at 60°C temperature was maintained. The method showed excellent linear response with correlation coefficient of R2 value of 0.999 respectively, which were within the limit of correlation R2 > 0.995. The forced degradation was carried with the developed and validated method to get the useful information about the degradation products, degradation pathways, and how the drug changes under the various stress condition. The degradation was within the limits (according to the guideline of ICH, 5-20%), while SUN® Peptide API showed <20% degradation in every condition.