title: Development and Validation of a High-Performance Thin-Layer Chromatographic Method for the Simultaneous Determination of Two Binary Mixtures Containing Ketorolac Tromethamine with Phenylephrine Hydrochloride and with Febuxostat.
abstract: A validated and highly selective high-performance thin-layer chromatography (HPTLC) method was developed for the determination of ketorolac tromethamine (KTC) with phenylephrine hydrochloride (PHE) (Mixture 1) and with febuxostat (FBX) (Mixture 2) in bulk drug and in combined dosage forms. The proposed method was based on HPTLC separation of the drugs followed by densitometric measurements of their spots at 273 and 320 nm for Mixtures 1 and 2, respectively. The separation was carried out on Merck HPTLC aluminum sheets of silica gel 60 F254 using chloroform-methanol-ammonia (7:3:0.1, v/v) and (7.5:2.5:0.1, v/v) as mobile phase for KTC/PHE and KTC/FBX mixtures, respectively. Linear regression lines were obtained over the concentration ranges 0.20-0.60 and 0.60-1.95 µg band(-1)for KTC and PHE (Mixture 1), respectively, and 0.10-1.00 and 0.25-2.50 µg band(-1) for KTC and FBX (Mixture 2), respectively, with correlation coefficients higher than 0.999. The method was successfully applied to the analysis of the two drugs in their synthetic mixtures and in their dosage forms. The mean percentage recoveries were in the range of 98-102%, and the RSD did not exceed 2%. The method was validated according to ICH guidelines and showed good performances in terms of linearity, sensitivity, precision, accuracy and stability.
authors: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Elmessalah, Alexandria 21521, Egypt felyazbi@yahoo.com.
authors: Fawzy A
authors: FA
authors: El Yazbi
authors: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Elmessalah, Alexandria 21521, Egypt.
authors: Ekram M
authors: EM
authors: Hassan
authors: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Elmessalah, Alexandria 21521, Egypt.
authors: Essam F
authors: EF
authors: Khamis
authors: Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Elmessalah, Alexandria 21521, Egypt.
authors: Marwa A A
authors: MA
authors: Ragab
authors: Analytical and Pharmaceutical Chemistry Department, Faculty of Pharmacy and Drug Manufacturing, Pharos University in Alexandria, Canal El-Mahmoudia Street, Smouha, Alexandria, Egypt.
authors: Mohamed M A
authors: MM
authors: Hamdy
mesh_terms: D002855:Chromatography, Thin Layer / Q000379:methods*; D045424:Complex Mixtures; D004304:Dosage Forms; D000069465:Febuxostat / Q000032:analysis*; D020911:Ketorolac Tromethamine / Q000032:analysis*; D057230:Limit of Detection; D010656:Phenylephrine / Q000032:analysis*; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D045424:Complex Mixtures; D004304:Dosage Forms; D000069465:Febuxostat; D010656:Phenylephrine; D020911:Ketorolac Tromethamine