Quantitation of 4-(4-Chl0R0Phenyl)-2-Pyrr0Lidin0Ne in Baclofen Powder and Tablets

Abstract

A high-pressure liquid chromatography method to quantify 4-(4-chlorophenyl)-2-pyrrolidinone which is present as an impurity in baclofen powder and its dosage forms has been developed. The USP-NF method for the determination of 4-(4-chlorophenyl)-2-pyrrolidinone in powder is based on TLC and is only qualitative. The developed method was successfully used to quantify 4-(4-chlorophenyl)-2-pyrrolidinone in powder (USP-NF limit 1%) and in tablets (USP-NF limit 5%). The method is accurate and reproducible with a percent error of 4% for powder and 3% for tablets.