AN EFFICIENT PROCESS FOR ISOLATION AND PURIFICATION OF VANCOMYCIN HYDROCHLORIDE IN COMPLIANCE WITH INTERNATIONAL PHARMACOPOEIAL STANDARDS

Vancomycin hydrochloride belongs to the glycopeptide antibiotics and has long been used to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) in patients with penicillin and cephalosporin allergy. Vancomycin hydrochloride has also long been used to protect patients against infections during surgery. However, Vancomycin hydrochloride has a very complicated structure and is not stable. Thus, isolation of high-purity vancomycin hydrochloride through microbial fermentation broths has long been more difficult when pharmacopeial standards are strictly enforced. This study improved the process of isolating and purifying vancomycin hydrochloride with high purity from Amycolatopsis orientalis fermentation broths. The first step of the process involved cell separation through microfiltration. The second step involved removal of impurities through adsorption resin column chromatography, using 20% methanol as elution solution. Ion exchange resins were used to precisely target the purification step, and then nanofiltration to concentrate the solution. Finally, crystallization or lyophilization steps were carried out to harvest the final material. Results showed that slow pH increase to 8.0 with 10% ammonia solution during base precipitation and subsequent lyophilization produced the highest purity and recovery of vancomycin hydrochloride. Vancomycin content of 95.65% was achieved with purity and recovery exceeding that specified by the United States Pharmacopeia (USP) and European Pharmacopoeia. The content of the impurities was below that specified by the United States Pharmacopeia (USP) and European Pharmacopoeia. This study provides a simple and fast process to isolate vancomycin hydrochloride with high purity that can now be grown commercially. This method meets international pharmaceutical standards.