Estimation of Ethylene glycol, Propylene glycol and Diethylene glycol in Levocetirizine dihydrochloride oral solution 0.5mg/mL by GC-FID

Abstract

The present study focuses on the development and validation of a gas chromatography-flame ionization detection (GC-FID) method to accurately quantify ethylene glycol (EG), propylene glycol (PG), and diethylene glycol (DEG) in the L-Cet Oral Solution, which contains Levocetirizine dihydrochloride at a concentration of 0.5 mg/mL. This method employs a straightforward, cost-efficient sample preparation technique, using a water-methanol solution as the diluent. Calibration standards for each analyte were formulated, and their concentrations in the oral solution were assessed under optimized chromatographic conditions. The method was subjected to validation according to International Council for Harmonisation (ICH) guidelines, evaluating critical parameters such as system suitability, specificity, linearity, precision, accuracy, and ruggedness. Linearity was observed for EG, PG, and DEG within the concentration range of 0.020–0.500%, with correlation coefficients exceeding 0.990, indicating strong linear relationships. Precision was assessed by conducting both intra-day and inter-day assays, yielding %RSD values that were well within acceptable limits. Ruggedness was verified by analyzing the samples using multiple instruments, columns, and analysts, all of which produced consistent results. Accuracy was evaluated by spiking samples with known concentrations of EG, PG, and DEG at the limit of quantification (LOQ), 100%, and 500% levels, with recovery values ranging from 98.0% to 102.0%. The method demonstrated no interference from the placebo or excipients, confirming its specificity. This validated method is highly reliable and can be employed for routine quality control testing of EG, PG, and DEG in pharmaceutical oral solutions, ensuring product safety and compliance with regulatory standards..