Abstract

DEVELOPMENT AND VALIDATION OF A HEADSPACE GAS CHROMATOGRAPHIC METHOD FOR DETERMINATION OF RESIDUAL SOLVENTS FOR FIVE ANTIDEPRESSANT DRUG SUBSTANCES

Twinkle Sakariya, Shradhdha Nakum, Piyush Kanani, Bhautik Mendapara and Anamik Shah*

Abstract

A simple and sensitive method for the determination of 18 residualsolvents for antidepressant drugs Bupropion, Fluoxetine, Milnacipran,Nortriptyline and Sertraline is developed using headspace techniquewith FID detector. These antidepressant drugs belong to differentclasses. The method was validated for repeatability, linearity, limit ofdetection, limit of quantification and recovery demonstrated as per theInternational Council for Harmonization (ICH) guidelines. Excellentresults were obtained, within the globally accepted validation referencevalues, particularly taking into account the low concentration levelsobtained.

Keywords: Gas chromatography, HS-GC, Residual solvents (RS), FID, Method development, Validation.