GC Method Validation for the Analysis of Menthol in Suppository Pharmaceutical Dosage Form

Abstract

Menthol is widely used as a fragrance and flavor in the food and cosmetic industries. It is also used in the medical and pharmaceutical fields for its various biological effects. Gas chromatography (GC) is considered to be a sensitive method for the analysis of menthol. GC chromatographic separation was developed using capillary column (VF-624) and a flame ionization detector (FID). The method was validated as per ICH guidelines for various parameters such as precision, linearity, accuracy, solution stability, robustness, limit of detection, and quantification. The tested validation parameters were found to be within acceptable limits. The method was successfully applied for the quantification of menthol in suppositories formulations. Quality control departments and official pharmacopeias can use our developed method in the analysis of menthol in pharmaceutical dosage formulation and raw material.