title: Development and validation of a stability-indicating high performance liquid chromatographic (HPLC) assay for biperiden in bulk form and pharmaceutical dosage forms.
abstract: Current compendial (USP) methods of assay for the analysis of biperiden in bulk form and pharmaceutical dosage forms involve the use of titrimetric and spectrophotometric procedures, respectively. These are non-selective and non-stability-indicating techniques. In this work, a stability-indicating high performance liquid chromatographic assay procedure has been developed and validated for biperiden. The liquid chromatographic separation was achieved isocratically on a symmetry C8 column (150 mm x 3.9 mm i.d., 5 microm particle size) using a mobile phase containing methanol-buffer (50:50, v/v, pH 2.50) at a flow rate of 1 ml/min and UV detection at 205 nm. The buffer was composed of sodium dihydrogen phosphate (50 mM) and 1-heptanesulfonic acid sodium salt (5 mM). The method was linear over the concentration range of 0.5-25 microg/ml (r=0.9998) with a limit of detection and quantitation 0.03 and 0.1 microg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay biperiden in bulk form and pharmaceutical dosage forms. Degradation products resulting from the stress studies did not interfere with the detection of biperiden and the assay is thus stability-indicating.
authors.affiliation: Department of Drug and Food Control, School of Pharmacy, Medical Sciences/University of Tehran, Tehran, Iran. alimohammadi@tums.ac.ir
authors.forename: A
authors.initials: A
authors.lastname: Mohammadi
authors.forename: A
authors.initials: A
authors.lastname: Mehramizi
authors.forename: F Aghaee
authors.initials: FA
authors.lastname: Moghaddam
authors.forename: L Erfani
authors.initials: LE
authors.lastname: Jabarian
authors.forename: M
authors.initials: M
authors.lastname: Pourfarzib
authors.forename: H N
authors.initials: HN
authors.lastname: Kashani
mesh_terms: D001712:Biperiden / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D018727:Muscarinic Antagonists / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012015:Reference Standards; D013056:Spectrophotometry, Ultraviolet
chemical_list: D018727:Muscarinic Antagonists; D004364:Pharmaceutical Preparations; D001712:Biperiden