title: Application of a validated method in the stability study of colistin sulfate and methylparaben in a veterinary suspension formulation by high-performance liquid chromatography with a diode array detector.
abstract: A methodology following International Cooperation on Harmonization for Veterinary Products (VICH) guidelines for the stability evaluation of colistin sulfate in a nonaqueous suspension pharmaceutical dosage form for veterinary use (via their drinking water) is described. This method monitors the percentage of colistin sulfate during the stability study of the preparation in drinking water and establishes the shelf life of the final product by a new high-performance liquid chromatography method which was developed and validated for the simultaneous determination of colistin sulfate [colistin A (Polymixin E1) and colistin B (Polymixin E2)] and methylparaben (Nipagin) using a diode array detector (DAD). The method uses a Kromasil C18 column and isocratic elution. The mobile phase consisted of an acetonitrile-sodium sulfate anhydrous solution (25 + 75) pumped at a flow rate of 1.5 mL/min. The DAD was set at 215 nm. The validation study was carried out according to the VICH guidelines in order to prove that the new analytical method meets the reliability characteristics, which include the fundamental criteria for validation: selectivity, linearity, precision, accuracy, and sensitivity. The method was applied during the quality control or stability studies of the suspension dosage form in order to quantify the drug (colistin) and preservative, and proved to be suitable for rapid and reliable quality control.
authors.affiliation: University of Barcelona, School of Pharmacy, Pharmacy and Pharmaceutical Technology Department, Unit of Pharmaceutical Technology, Avda Joan XXIII s/n 08028, Barcelona, Spain. perezlo@ub.edu
authors.forename: Pilar
authors.initials: P
authors.lastname: Pérez-Lozano
authors.forename: Encarna
authors.initials: E
authors.lastname: García-Montoya
authors.forename: Anna
authors.initials: A
authors.lastname: Orriols
authors.forename: Montse
authors.initials: M
authors.lastname: Miñarro
authors.forename: Josep Ramon
authors.initials: JR
authors.lastname: Ticó
authors.forename: Josep Maria
authors.initials: JM
authors.lastname: Suñé-Negre
mesh_terms: D000097:Acetonitriles / Q000737:chemistry; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002845:Chromatography / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003091:Colistin / Q000032:analysis*; D008956:Models, Chemical; D010100:Oxygen / Q000737:chemistry; D010226:Parabens / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013696:Temperature; D019155:Veterinary Drugs / Q000032:analysis* / Q000737:chemistry*
chemical_list: D000097:Acetonitriles; D010226:Parabens; D019155:Veterinary Drugs; C015358:methylparaben; D010100:Oxygen; C032159:acetonitrile; D003091:Colistin