title: Development and validation of impurity-profiling UPLC method for the determination of sodium cromoglicate and tetryzoline hydrochloride: Application on rabbit aqueous humor.
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 (1.7μm 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.
authors.affiliation: Pharmaceutical Chemistry department, Faculty of Pharmaceutical sciences & Pharmaceutical industries, Future University in Egypt (FUE), 12311 Cairo, Egypt.
authors.forename: Hayam M
authors.initials: HM
authors.lastname: Lotfy
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787 6th October, Egypt. Electronic address: drsarahsalah@gmail.com.
authors.forename: Sarah S
authors.initials: SS
authors.lastname: Saleh
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr-El Aini, 11562 Cairo, Egypt.
authors.forename: Nagiba Y
authors.initials: NY
authors.lastname: Hassan
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Deraya University, Minia, Egypt.
authors.forename: Hesham
authors.initials: H
authors.lastname: Salem
mesh_terms: D000818:Animals; D001082:Aqueous Humor / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004205:Cromolyn Sodium / Q000032:analysis*; D004340:Drug Contamination; D007093:Imidazoles / Q000032:analysis*; D057230:Limit of Detection; D016014:Linear Models; D011817:Rabbits; D015203:Reproducibility of Results
chemical_list: D007093:Imidazoles; D004205:Cromolyn Sodium; C005810:tetrahydrozoline
keywords: Aqueous humor; Degradation; Sodium cromoglicate; Tetryzoline HCl; UPLC