title: Development and validation of a micellar electrokinetic capillary chromatography method for the determination of goserelin and related substances.
abstract: An MEKC method for the analysis of goserelin and related substances has been developed using a combination of additives including CTAB, β-CD, and sodium hexanesulfonate. For this assay, the running buffer (pH and additives) and separation conditions (voltage and temperature) were optimized. The optimized system was the following: 200 mM 6-aminocaproic acid buffer (pH 4.2) supplemented with 175 mM CTAB, 3.0% w/v β-CD, and 20 mM sodium hexanesulfonate; the voltage was 10 kV in reverse polarity mode, the temperature was 20°C, and UV detection was measured at 220 nm. The method was qualified by evaluating the specificity, precision, linearity, accuracy, LOD, and LOQ. According to validation experiments, the optimized method was specific, accurate, and repeatable and satisfied the requirements for the analysis of goserelin and related substances. Compared with the RP-HPLC method, the MEKC method better solved the problem of overlapping impurity signals, and the migration time required was shorter. This method can be used for quality control and for the analysis of goserelin and its related substances.
authors.affiliation: School of Pharmacy, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University ), Ministry of Education, Yantai University, Yantai, P.R. China.
authors.forename: Feifei
authors.initials: F
authors.lastname: Gong
authors.affiliation: National Institutes for Food and Drug Control, Beijing, P. R. China.
authors.forename: Huaxin
authors.initials: H
authors.lastname: Yang
authors.affiliation: State Key Laboratory of Long-acting and Targeting Drug Delivery System, Luye Pharma Group Ltd, Yantai, P. R. China.
authors.forename: Wen
authors.initials: W
authors.lastname: Sun
authors.affiliation: State Key Laboratory of Long-acting and Targeting Drug Delivery System, Luye Pharma Group Ltd, Yantai, P. R. China.
authors.forename: Junzi
authors.initials: J
authors.lastname: Cao
authors.affiliation: School of Pharmacy, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, Key Laboratory of Molecular Pharmacology and Drug Evaluation (Yantai University ), Ministry of Education, Yantai University, Yantai, P.R. China.|State Key Laboratory of Long-acting and Targeting Drug Delivery System, Luye Pharma Group Ltd, Yantai, P. R. China.
authors.forename: Wanhui
authors.initials: W
authors.lastname: Liu
mesh_terms: D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D004340:Drug Contamination; D017273:Goserelin / Q000032:analysis* / Q000737:chemistry / Q000592:standards*; D057230:Limit of Detection; D016014:Linear Models; D015203:Reproducibility of Results; D013501:Surface-Active Agents / Q000737:chemistry
chemical_list: D013501:Surface-Active Agents; D017273:Goserelin
keywords: Goserelin; Micellar electrokinetic capillary chromatography; Peptide drugs; Related substances