title: Development and validation of a reversed-phase HPLC method for simultaneous analysis of butylhydroxyanisol, simvastatin and its impurities in tablet dosage forms.
abstract: A simple, rapid, and sensitive RP-HPLC method using photodiode array detection was developed and validated for the simultaneous determination of butylhydroxyanisol and simvastatin with its impurities in tablet forms. Chromatographic separation was achieved on a Phenomenex Hypersil (250×4.6 mm, 5 μm) column using the mobile phase acetonitrile-sodium acetate (12 mM) buffered to 4.2 with glacial acetic acid. The flow rate was 1.7 mL/min, and the UV detection were made at 238 nm for simvastatin and its impurities and at 290 nm for butylhydroxyanisol. The system suitability solution used for peak impurity identification was generated in-situ without use of any impurity reference standard. The method was validated according to ICH Q2(R1) guidelines, and the acceptance criteria for accuracy, precision, linearity, specificity, robustness, LOD, and LOQ, were met in all cases. Moreover, the reproducibility results obtained by 22 Official Medicines Control Laboratories (OMCL) of European Directorate were satisfactory. The compounds selected for impurity validation were based on those found during long term and accelerate stability studies carried out on several formulation tablets from Moroccan and other markets. The described method was robust and successfully applied in quality control laboratories for routine analysis to determine the butylhydroxyanisol and simvastatin with its impurities content in tablet dosage forms.
authors.affiliation: Research team of pharmaceutical and toxicological analysis, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, Mohammed V university, Soussi, Rabat, Morocco; Physicochemical service, drugs quality control laboratory, division of drugs and pharmacy, Ministry of Health, Rabat, Morocco.
authors.forename: M
authors.initials: M
authors.lastname: El Karbane
authors.affiliation: Physicochemical service, drugs quality control laboratory, division of drugs and pharmacy, Ministry of Health, Rabat, Morocco; Institut de formation aux carrières de santé de Rabat, avenue Hassan-II, kilomètre 4,5, 10000 Rabat, Morocco. Electronic address: azougaghma@yahoo.fr.
authors.forename: M
authors.initials: M
authors.lastname: Azougagh
authors.affiliation: Research team of pharmaceutical and toxicological analysis, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, Mohammed V university, Soussi, Rabat, Morocco; Physicochemical service, drugs quality control laboratory, division of drugs and pharmacy, Ministry of Health, Rabat, Morocco.
authors.forename: M
authors.initials: M
authors.lastname: Amood A L-Kamarany
authors.affiliation: Physicochemical service, drugs quality control laboratory, division of drugs and pharmacy, Ministry of Health, Rabat, Morocco.
authors.forename: H
authors.initials: H
authors.lastname: Bouchafra
authors.affiliation: Research team of pharmaceutical and toxicological analysis, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, Mohammed V university, Soussi, Rabat, Morocco.
authors.forename: Y
authors.initials: Y
authors.lastname: Cherrah
authors.affiliation: Research team of pharmaceutical and toxicological analysis, laboratory of pharmacology and toxicology, faculty of medicine and pharmacy, Mohammed V university, Soussi, Rabat, Morocco.
authors.forename: A
authors.initials: A
authors.lastname: Bouklouze
mesh_terms: D002083:Butylated Hydroxyanisole / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D004355:Drug Stability; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000032:analysis*; D057230:Limit of Detection; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D019821:Simvastatin / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets / Q000032:analysis
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D013607:Tablets; D002083:Butylated Hydroxyanisole; D019821:Simvastatin
keywords: CLHP indicatrice de stabilité; Dégradation forcée impuretés de simvastatine; Méthode de validation; Simvastatin; Simvastatin impurities; Simvastatine; Stability indicating HPLC; Stress degradation; Validation method