Investigation on Impurity Profiling and Degradation Behavior of WCK 771

WCK 771 is a novel antibacterial drug recently launched in India for the treatment of acute bacterial skin and skin structure infections (ABSSSI). This report describes identification, quantification of impurities and degradation products (DPs) in the drug substance. The research embraces development of two reversed phase liquid chromatographic (RP-LC) methods; one mass spectrometer (MS) compatible method for identification and another UV detection method for the quantification of impurities. Four process impurities and eight DPs were identified using liquid chromatography tandem mass spectrometry (LC–MS/MS). The chromatographic separation was achieved on C18 column applying gradient elution. WCK 771 was subjected to hydrolytic, oxidative, photolytic and thermal stress. Degradation was observed only in acidic and oxidative environment. Validated UV method is accurate and precise to quantify impurities with accuracy greater than 98.71% and precision of less than 2.82%. The method is highly sensitive to detect impurities as low as 0.17 ng on column. The developed method is employed for quality control and stability studies of the new drug substance.