Abstract

A QUANTITATIVE DETERMINATION OF CHLOROACETIC ACIDS IN CETIRIZINE HYDROCHLORIDE API BY GAS CHROMATOGRAPHY

Rajendra Phadke*, Swapnil Patil and Dr. Amit Gosar

Abstract

A gas chromatographic procedure has been developed for the determination of chloroacetic acid in cetirizine hydrochloride API. Due to the high polar acidic in nature of chloroacetic acid, compound was not eluted properly in Gas chromatograph column. Therefore derivatizating technique need, Compound was derivatised using reagent N, OBist (trimethylsilyl) trifluoroacetamide (BSTFA) in presence of methyl tert-butyl ether solvent prior to their analysis via gas chromatogram coupled with a flame ionization detector (GC-FID). The derivatised chloroacetic acid was well separated on HP-5 column, 30 m, 0.32 mm ID, 0.25m film thickness. The oven program was 40°C initial temper ature hold time 8.0 minute, then 20C ramp per min upto 200C then hold to 4.0 minute. This analytical method was validated as per international conference on harmonization guideline for parameter specificity, linear, accuracy, precision and limit of detection and limit of quantitation. The obtained recovery of chloroacetic acid was found to be 90% to 110% and detection and quantitation limit was 0.0081% and 0.025% with respective to cetirizine hydrochloride API. The linearity was ranging from 0.08 to 0.23% with respective to cetirizine hydrochloride API and the observed correlation coefficients was 0.9990. The repeatability was evaluated against limit concentration and at LOQ level concentration, which were obtained as 1.82% and 2.05%.

Keywords: Cetirizine hydrochloride API, Gas chromatograph, Chloroacetic acid, Derivative, Method development, Validation.