title: New Salting Out Stability-Indicating and Kinetic Thin Layer Chromatographic Method for Determination of Glimepiride and Metformin HCl Binary Mixture.
abstract: A simple, selective salting out and stability-indicating thin layer chromatographic (SOTLC) technique was developed for determination of two antidiabetic drugs; glimepiride and metformin HCl in pure and in tablets as a binary mixture. Separation was performed on silica gel 60 F254 plates using aqueous ammonium sulfate and acetonitrile (7:3, v/v) as a mobile phase. The Rf values were 0.26 ± 0.02 and 0.73 ± 0.02 for glimepiride and metformin HCl, respectively. The separated bands were scanned at λ 237 nm using CAMAG TLC scanner III. The proposed method focusing on study of all the factors that play important role in the mechanism of salting out process. The proposed method was validated according to ICH guidelines and complied with USP31-NF26 validation guidelines. The correlation coefficients of calibration curves were 0.996 and 0.997 for glimepiride and metformin HCl, respectively, in the concentration range of 60-1,400 ng/band for both drugs. The investigated drugs were also subjected to acidic, basic, oxidative and photo-degradation and kinetic study was carried out.
authors.affiliation: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, B.O. 71526, Assiut, Egypt gadeedegypt2008@yahoo.com.
authors.forename: Yahya Abduh Salim
authors.initials: YA
authors.lastname: Mohamed
authors.affiliation: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, B.O. 71526, Assiut, Egypt.
authors.forename: Abdel Maaboud Ismail
authors.initials: AM
authors.lastname: Mohamed
authors.affiliation: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, B.O. 71526, Assiut, Egypt.
authors.forename: Fardous Abdel-Fattah
authors.initials: FA
authors.lastname: Mohamed
authors.affiliation: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, B.O. 71526, Assiut, Egypt.
authors.forename: Sameh Abdel-Raouf
authors.initials: SA
authors.lastname: Ahmed
mesh_terms: D002138:Calibration; D002855:Chromatography, Thin Layer / Q000379:methods*; D004355:Drug Stability; D057230:Limit of Detection; D016014:Linear Models; D008687:Metformin / Q000032:analysis* / Q000737:chemistry; D015203:Reproducibility of Results; D013453:Sulfonylurea Compounds / Q000032:analysis* / Q000737:chemistry; D013607:Tablets
chemical_list: D013453:Sulfonylurea Compounds; D013607:Tablets; C057619:glimepiride; D008687:Metformin