GC-MS Method for determination of 4- Aminophenol Impurity in Paracetamol Tablet Formulation, International Journal of Engineering and Technology

Abstract

A sensitive and selective method based on gas chromatography hyphenated to mass spectrometry (GC–MS) for the screening of developed and validated a method for the rapid analysis of impurities in paracetamol tablet formulation, by direct injection using mass detector. The analysis of ‘4-aminophenol in paracetamol tablet formation by direct injection using mass detector’, have been reported for the first time. Our work deals with development of a novel gas chromatography method with mass detector which can be use to determine the content of 4-aminophenol in paracetamol tablet formulation, by direct injection using mass detector. For method validation parameters such as specificity, Non-Inference from other peaks, Limit of detection and quantification, precision, accuracy LOD and LOQ Precision etc. In this method validation study simple, rapid and selective chromatographic procedures were established for the simultaneous determination of 4- aminophenol in paracetamol commercially available tablets. The GC-MS method is direct, requiring minimal sample preparation and made use of the total ion current detection. The method needs no derivatization or pretreatment of the target compound. The described validated chromatographic method offer specificity advantage over the spectrophotometric based nonseparation method. Finally, the proposed method was found accurate and precise, thus making them convenient for quality purposes