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Development and validation of headspacemethod for determination of residual solvents in doxorubicin hydrochloride bulk drug

R.S.Lokhande, P.U.Singare, P.V.Jadhav

Organic volatile impurities by Headspace GC method was developed and validated for Doxorubicin hydrochloride bulk drug for its four residual solvents. Analysis was performed on Perkin Elmer HS 40 system with auto injector. 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 85° 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 quantitation, linearity, precision, accuracy and robustness. The method was successfully used to quantitate the levels of specified limit for residual solvents in Doxorubicin hydrochloride bulk drug.