Forced Degradation Study of Sun Peptide for Identification and Characterization of Generated Impurities

Abstract

SUN Peptide-1 and SUN Peptide-2 is a novel drug. In this study, stability indicating method of SUN Peptide-1 and SUN Peptide-2 was developed and in the presence of process related impurities and degradation products using HPLC. The chromatographic separation for SUN Peptide-1 was achieved on XSelect CSH C18 (2.5 μm, 4.6 X 150 mm) at 60°C. The peaks of SUN Peptide-1 and its known impurities were separated using Potassium dihydrogen orthophosphate Buffer: Acetonitrile (90:10, %V/V/V) as mobile phase A and Buffer: Acetonitrile (30:70, % V/V) as mobile phase B in gradient program. The analytes were monitored in the range 200-400 nm using UV- Visible detector. The forced degradation study of SUN Peptide-1 showed that the drug is susceptible to degrade in alkaline & oxidative condition. The chromatographic separation for SUN Peptide-2 was achieved on Xbridge Peptide BEH C18 (130 A°, 3.5 μm, 4.6 X 250 mm). The peaks of SUN Peptide-2 and its known impurities were separated using Potassium dihydrogen orthophosphate Buffer: Acetonitrile (90:10, %V/V/V) as mobile phase A and Buffer: Acetonitrile (30:70, % V/V) as mobile phase B in gradient program. The analytes were monitored in the range 200-400 nm using UV- Visible detector. The forced degradation study of SUN Peptide-2 showed that the drug is susceptible to degrade in acidic and alkaline condition. To identify the major degradation products MS compatible method was developed using Water: 0.1% Trifluoro acetic acid buffer: ACN (90:10, %V/V/V) as mobile phase A and 0.1% Trifluoro acetic acid buffer: ACN (30:70, %V/V/V) as mobile phase B. The HRMS study revealed 4 different degradation products. Possible degraded products are listed in thesis.