GAS CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF RESIDUAL ISOPROPYL ALCOHOL CONTENT IN PHARMACEUTICALS

Abstract

The analysis of residual solvents in pharmaceuticals such as drugs, excipients etc are important because most of them contain residual solvents in which isopropyl alcohol (IPA) is mainly present. Residual solvents are entrapped within the formulation either during synthesis, extraction of drug substances or during coating of formulations. Many residual solvents generally cannot be removed completely by standard manufacturing process or techniques and are left behind, preferably at low levels in formulations. Pharmaceutical excipients containing IPA were taken for gas chromatographic method development and validation. A simple, sensitive, and precise gas chromatographic method for the analysis of pharmaceutical excipients has been developed, validated and used for the determination of IPA. Nitrogen was used as carrier gas and method development involved optimization of chromatographic conditions such as; selection of column, pH, flow rate, temperature, and concentration. Method performance is determined primarily by the quality of the procedure itself. The two factors that are most important in determining the quality of the method are selective recovery and standardization. Properly developed method was finally utilized for validation. The search for the reliable range of a method and continuous application of this knowledge is called validation. Validation was performed according to the requirement of ICH validation guidelines. During method validation, parameters such as precision, linearity, accuracy, limit of quantification 8 detection and specificity were evaluated, which remained within acceptable limits. The results obtained from validation proved that the proposed method was scientifically simple and reliable. The proposed GC method was successfully applied for the quantification of IPA present in pharmaceutical excipients.