Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

In the present study, Levocetirizine was selected for which UPLC method was developed, validated and comprehensive stress testing was carried out according to ICH guideline Q1A (R2). Th e system consisted of a Pump (model Jasco X-LC 3185PU), with sampler programmed at 1-5 μL capacity per injection. Th e detector consisted of a UV/ VIS (Jasco X-LC 3177 UV) model operated at a wavelength of 230 nm. Data was integrated using ChromNAV soft ware, LC-Net II/ADC system. Successful separation of drug from degradation products formed under stress conditions was achieved on a X-PressPak V-C 18 (50 mm � 2.0 mm, 1.8 μ) from Japan with isocratic conditions and simple mobile phase containing acetonitrile: water (55: 45) at fl ow rate of 0.1 mL/min with R f value 1.40 � 0.02 and the column oven temperature was set at 25�C. Levocetirizine is subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Additionally, the solid drug is subjected to 50�C for 60 days in dry-bath, and to the combined eff ect of temperature and humidity, with and without light, at 40�C/75% RH. Th e drug was found to degrade signifi cantly in acidic, alkaline and oxidative conditions whereas the drug was found to be stable in photo and neutral condition. Th e drug is relatively stable in the solid-state, except formation of minor products under accelerated conditions. Th e linear regression analysis data for the calibrat ion plots showed a good linear relationship over the concentration range of 1-6 μg/mL. Th e mean (�RSD) values of slope, intercept and correlation coeffi cient were 909.91 (�1.23), 352.47 (�0.76) and 0.9958 (�0.69), respectively. Th e method was validated for precision, robustness and recovery. Th e limit of detection (LOD) and limit of quantitation (LOQ) was 0.4 and 0.5 μg/mL respectively. Statistical analysis showed that the method is repeatable and selective for the estimation of Levocetirizine. Since the method can separate the drug from its degradation products, it can be used to monitor stability. UPLC provides more resolution while reducing runtime and improves sensitivity for analysis of compounds. UPLC fulfi ls the promise of increasing resolution, speed and sensitivity.

Biography