title: Multivariate development and validation of a stability-indicating HPLC method for the determination of glimepiride in tablets.
abstract: This paper describes the multivariate development of a stability-indicating HPLC method for the quantification of glimepiride in pharmaceutical tablets. Full factorial design, Doehlert design, and response-surface methodology were used in conjunction with the desirability function approach. This procedure allowed the adequate separation of glimepiride from all degradant peaks in a short analysis time (about 9 min). This HPLC method uses potassium phosphate buffer (pH 6.5; 27.5 mmol/L)-methanol (34 + 66, v/v) mobile phase at a flow rate of 1.0 mL/min and UV detection at 228 nm. A Waters Symmetry C18 column (250 x 4.6 mm, 5.0 pm) at controlled room temperature (25 degrees C) was used as the stationary phase. The method was validated according to International Conference on Harmonization guidelines and demonstrated linearity from 2 to 40 mg/L glimepiride, selectivity, precision, accuracy, and robustness. The LOD and LOQ were 0.315 and 1.050 mg/L, respectively. The multivariate strategy adopted in this work can be successfully applied in routine laboratories because of its fast optimization without the additional cost of columns or equipment.
authors.affiliation: Universidade Estadual Paulista, Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas, Rodovia Araraquara-Jaú, km 1, CEP 14801-902, Araraquara, SP, Brazil.
authors.forename: Rudy
authors.initials: R
authors.lastname: Bonfilio
authors.forename: Carolina
authors.initials: C
authors.lastname: Peres
authors.forename: Hérida R N
authors.initials: HR
authors.lastname: Salgado
authors.forename: Magali B
authors.initials: MB
authors.lastname: De Araújo
authors.forename: César R T
authors.initials: CR
authors.lastname: Tarley
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D013453:Sulfonylurea Compounds / Q000032:analysis* / Q000737:chemistry; D013607:Tablets
chemical_list: D013453:Sulfonylurea Compounds; D013607:Tablets; C057619:glimepiride