title: Evaluation of an International Pharmacopoeia method for the analysis of nelfinavir mesilate by liquid chromatography.
abstract: A gradient LC method for the determination of related substances in nelfinavir mesilate (NFVM) has been recently published in the International Pharmacopoeia. The method uses a base deactivated reversed phase C18 column (25 cm x 4.6 mm I.D.), 5 microm kept at a temperature of 35 degrees C. The mobile phases consist of acetonitrile, methanol, phosphate buffer pH 3.4 and water. The flow rate is 1.0 ml/min. UV detection is performed at 225 nm. A system suitability test (SST) is described to govern the quality of the separation. The separation towards NFVM components was investigated on 18 C18 columns and correlation was made with the column classification system developed in our laboratory. The method was evaluated using a Hypersil BDS C18 column (25 cm x 4.6 mm I.D.), 5 microm. A two level fractional factorial design was applied to examine the robustness of the method. The method shows good selectivity, precision, linearity and sensitivity. Seven commercial samples were examined using this method.
authors.affiliation: Laboratorium voor Farmaceutische Analyse, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, O & N 2, Postbus 923, Herestraat 49, B-3000 Leuven, Belgium.
authors.forename: Raja Satyanarayana
authors.initials: RS
authors.lastname: Yekkala
authors.forename: Stephanie
authors.initials: S
authors.lastname: Vandenwayenberg
authors.forename: Jos
authors.initials: J
authors.lastname: Hoogmartens
authors.forename: Erwin
authors.initials: E
authors.lastname: Adams
mesh_terms: D002853:Chromatography, Liquid; D006863:Hydrogen-Ion Concentration; D038622:Internationality; D019888:Nelfinavir / Q000032:analysis* / Q000737:chemistry / Q000302:isolation & purification; D010602:Pharmacopoeias as Topic / Q000592:standards*; D012044:Regression Analysis; D015203:Reproducibility of Results; D013696:Temperature
chemical_list: D019888:Nelfinavir