Development and validation of a reversed phase High Performance Liquid Chromatography method for content evaluation of some brands of paracetamol tablets sold in Abuja, Nigeria

Abstract

A simple, rapid, accurate and economical isocratic Reversed Phase High Performance Liquid Chromatography (RPHPLC) method was developed, validated and used for the evaluation of content of different brands of paracetamol tablets. The method was validated according to ICH guidelines and may be adopted for the routine analysis of paracetamol in dosage forms both as single or combined formulation. Twelve brands of paracetamol tablets were randomly purchased from pharmacy stores around Abuja, the Federal Capital Territory (FCT) of Nigeria and coded accordingly. Samples were analyzed using a validated isocratic RP-HPLC method with UV detection at 254 nm at ambient temperature. Analysis time was 6 minutes. The inter and intraday precision coefficient of variance for 2 and 8 μg/ml were less than 5% and the percentage recovery was more than 90%. Percentage contents ranged between 93.03- 126.43% (±0.81-11.12). 41.7% of the assessed brands passed while 58.3% failed with the values being either above or below the BP specification of 95-105% for percentage content of paracetamol in tablets. Keywords: Paracetamol; Reversed Phase HPLC; Routine Analysis; Pharmacy Stores