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Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF RESIDUAL SOLVENTS IN SIMVASTATIN BY USING GAS CHROMATOGRAPHY – HEAD SPACE TECHNIQUE

J.Venkata Krishna*, B. Pavani Venkat, A.Ajitha and V.Uma Maheswara Rao.

ABSTRACT

A novel, simple and economical analytical method has been developed for the estimation of residual solvents in Simvastatin bulk drug form with greater précised, specific method. Separation was achieved on ZB-624 (30.0m X 0.53mm X 3.0μm). The detection was carried out by using Flame Ionization Detector Helium was used as a carrier gas at a flow rate of 40 ml/min. The column temperature programmed from 350c to 2400c while the temperature of injection port and detector were Maintained at 1800c and 2600c respectively. The retention times where obtained at 4.5, 7.3, 8.1, 9.4, 9.8, 10.1, 14.1 min for Methanol, ACN, N-Hexane, Ethyl Acetate, THF, Cyclohexane and Toluene respectively. The developed method was validated As per ICH guidelines and it found to be specific, précised, rugged, with the linearity range from 50-150 %. Thus the proposed method can be successfully applied for Estimation of residual solvents in simvastatinand in routine analysis work.

Keywords: Simvastatin, Methanol, ACN, N-Hexane, Ethyl Acetate, THF, Cyclohexane.


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