Method Development and Validation of Indigenously Isolated Caspofungin Acetate and its related Substances using RP-HPLC Method

Abstract

Caspofungin is prepared from a precursor PneumocandinB0 derived from a fungus Glarea lozoyensis. Prepared crude caspofungin acetate has many impurities, namely, A, B, D, E and PneumocandinB0, and these impurities vary slightly in chemical or structural composition and need to be eliminated by purification. The present study involves the preparation of caspofungin acetate from PneumocandinB0, followed by purification and method development for detecting caspofungin and its related substances.”We used a high-tech liquid chromatograph system, which included components like the Agilent 1260 infinity quaternary pump module, a sophisticated MWD detector, and the Empower 3 data handling system. To separate and analyze substances, we employed an analytical column made of stainless steel. This column was 150 mm long and had an internal diameter of 3.0 mm. It was filled with octadecyl silane chemically bonded to porous silica particles, each with a tiny diameter of 3 micrometers. The test method underwent validation to ensure it could accurately identify specific elements, detect minimal quantities, establish the lowest measurable amounts, maintain linearity, demonstrate precision, achieve accuracy, and suitably handle sample solutions and the system.” and the developed test method is suitable and can be introduced into the routine use for the detection of caspofungin acetate and its related substances.