title: Determination of alendronate in pharmaceutical dosage formulations by ion chromatography with conductivity detection.
abstract: A method was developed and validated for the direct determination in pharmaceutical dosage formulations of alendronate, a non-chromophoric compound. It is based on the use of single-column ion chromatography with conductivity detection that obviates the need for the tedious chemical derivatization procedures that are required for UV and fluorescence detection. Diluted samples of 0.05 mg/ml were chromatographed directly on a Waters IC-Pak HR anion-exchange column or a Dionex OmniPac PAX-100 column with dilute nitric acid as the mobile phase followed by conductivity detection. The method was validated and shown to be precise, accurate and specific for the assay of alendronate in intravenous (i.v.) solution and tablet formulations. The ruggedness of the assay was studied by generating data from four different instruments. Also established was the equivalence between this method and a previously reported high-performance liquid chromatographic method with 9-fluorenylmethyl chloroformate derivatization and UV detection. Application of the method to the determination of alendronate in i.v. and tablet formulations is presented and the performances of the Waters IC-Pak HR and Dionex OmniPac columns are discussed.
authors.affiliation: Merck Sharp & Dohme Research Laboratories, West Point, PA 19486.
authors.forename: E W
authors.initials: EW
authors.lastname: Tsai
authors.forename: D P
authors.initials: DP
authors.lastname: Ip
authors.forename: M A
authors.initials: MA
authors.lastname: Brooks
mesh_terms: D019386:Alendronate; D002852:Chromatography, Ion Exchange / Q000379:methods* / Q000592:standards; D004164:Diphosphonates / Q000032:analysis*; D012996:Solutions; D013607:Tablets / Q000032:analysis; D013810:Therapeutic Equivalency
chemical_list: D004164:Diphosphonates; D012996:Solutions; D013607:Tablets; D019386:Alendronate