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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 residual
solvents for antidepressant drugs Bupropion, Fluoxetine, Milnacipran,
Nortriptyline and Sertraline is developed using headspace technique
with FID detector. These antidepressant drugs belong to different
classes. The method was validated for repeatability, linearity, limit of
detection, limit of quantification and recovery demonstrated as per the
International Council for Harmonization (ICH) guidelines. Excellent
results were obtained, within the globally accepted validation reference
values, particularly taking into account the low concentration levels
obtained.

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


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