Development and Validation of Headspace （顶部空间的发展和验证）.pdfVIP

American Journal of Chemistry 2012, 2(2): 1-5 DOI: 10.5923/j.chemistry01 Development and Validation of Headspace Method for Determination of Residual Solvents in Diphenoxylate Hydrochloride Bulk Drug 1 2,* 1 R. S. Lokhande , P. U. Singare , P. V. Jadhav 1Department of Chemistry, University of Mumbai, Vidyanagari, Santacruz, 400098, Mumbai 2Department of Chemistry, Bhavan’s College, Andheri, 400058, Mumbai pravinsingare@ Abstract Organic volatile impurities by Headspace GC method was developed and validated for Diphenoxylate hydro- chloride bulk drug for its seven residual solvents. Analysis was performed on Perkin Elmer HS 40 system with auto injector. Carrier gas Helium was used with constant flow rate of 2.5mL/min as carrier gas and the separation of residual solvents were achieved on DB-5 column. The thermostat temperature was 125 °C for 20 minute for each vial and after the equilibration the vials were pressurized and injected on GC column. FID detector was used for detection. The parameter for which the method was validated included specificity, limit of detection and quantification, linearity, precision, accuracy and robustness. The method was successfully used to quantify the levels of specified limit for residual solvents in Diphenoxylate hydrochloride bulk drug. Keywords Diphenoxylate Hydrochloride, Headspace GC; Residual Solvent; Quantification; Impurity Profiling benzene is possible if it is not controlled at the released of 1. Introduction sol