Development and validation of impurity-profiling UPLC method for the determination of sodium cromoglicate and tetryzoline hydrochloride: Application on rabbit aqueous humor
Date
2015
Authors
Journal Title
Journal ISSN
Volume Title
Type
Article
Publisher
Elsevier
Series Info
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
1006
1006
Scientific Journal Rankings
Abstract
Sodium cromoglicate (SCG), antihistaminic agent, and tetryzoline hydrochloride (TZH), a sympathomimetic agent, are formulated together as an ophthalmic preparation. An ultra-performance liquid chromatographic method with UV detection (UPLC-UV) was developed and validated for the quantitative determination of SCG and TZH in rabbit aqueous humor. Due to the instability of both SCG and TZH under alkaline conditions, the UPLC method was applied for their determination in the presence of their possible degradation impurities. The separation was performed using C18 column (1.7?m particle size) and isocratic elution system with methanol: 1% o-phosphoric acid (65: 35, v/v). The optimum flow rate was 0.5ml/min and the detection was done at 230nm. The suggested method was validated in compliance with the ICH guidelines and was successfully applied for determination of sodium cromoglicate (SCG) and tetryzoline HCl (TZH) as prepared synthetically in laboratory mixtures, and in the presence of their alkali-induced degradation impurities. The suggested method was effectively applied the determination of spiked rabbit aqueous humor samples as well as commercial pharmaceutical formulation. � 2015 Elsevier B.V.
Description
Scopus
MSA Google Scholar
MSA Google Scholar
Keywords
Aqueous humor, Degradation, Sodium cromoglicate, Tetryzoline HCl, UPLC, Biomimetics, Chromatographic analysis, Degradation, Impurities, Liquid chromatography, Particle size, Sodium, Aqueous humor, Chromatographic methods, Pharmaceutical formulation, Quantitative determinations, Sodium cromoglicate, Sympathomimetic agents, Tetryzoline HCl, UPLC, Body fluids, cromoglycate disodium, methanol, phosphoric acid, tetryzoline, cromoglycate disodium, imidazole derivative, tetryzoline, accuracy, animal tissue, aqueous humor, Article, controlled study, drug degradation, drug determination, drug stability, elution, experimental rabbit, flow rate, limit of detection, limit of quantitation, nonhuman, priority journal, separation technique, ultra performance liquid chromatography, validation study, animal, chemistry, drug contamination, high performance liquid chromatography, procedures, rabbit, reproducibility, statistical model, Animals, Aqueous Humor, Chromatography, High Pressure Liquid, Cromolyn Sodium, Drug Contamination, Imidazoles, Limit of Detection, Linear Models, Rabbits, Reproducibility of Results