DETERMINATION AND VALIDATION FOR ACETIC ACID CONTENT PRESENT IN FLURBIPROFEN BY GC-HS TECHNIQUE

Most solvents are organic volatile chemicals that are used in the manufacture of APIs, excipients and pharmaceuticals. Therefore, there is no therapeutic use of such solvents and they also affect the quality and stability of not only drugs but also their product and should be eliminated to the extent possible to meet product specifications and other quality-based requirements. These residual solvents cannot be completely removed; therefore, they should be within acceptable limits according to regulatory guidelines such as ICH guidelines. GC-HS is the most commonly used technique used for the analysis of volatile solvents. The aim of this work is therefore to develop a simple, specific GC-HS method for the determination of residual solvents in Flurbiprofen. The method was developed accurately and validation parameters were explained. Chromatographic condition was RDS/AL/GC – 03 Parkin Elmer instrument and RDS/AL/GC – 05 by Agilent, column: GSBP- 624 (30m x 0.53 mm x 3.0 µm). The parameters like as Specificity, Precision, Accuracy, Linearity and Range, Limit of Detection (LOD) and Limit of Quantitation testing with Acetone, Benzene, Dichloromethane, Ethyl Acetate, Toluene, Isopropyl alcohol and Bromobenzene. All validation parameters are used in the routine and stability analysis.