title: A validated reversed phase HPLC method for the determination of process-related impurities in almotriptan malate API.
abstract: An isocratic reversed phase liquid chromatographic (RP-LC) method has been developed and subsequently validated for the determination of almotriptan malate and its process-related impurities. Separation was achieved with a Phenomenex, Gemini, C-18 column and sodium phosphate buffer (pH adjusted to 7.6): acetonitrile (80:20, v/v) as eluent, at a flow rate of 1.5 mL/min. UV detection was performed at 227 nm. The method is simple, rapid, selective, accurate and stability indicating. The described method is linear over a range of LOQ, 1.5 ug/mL (150% of the specification limit) for all the process-related impurities. The method precision for the determination of related compounds was below 1.0% R.S.D. The accuracy of the method demonstrated at 4 levels in the range of 25-150% of the specification limit and the recovery of impurities were found to be in the range of 96-102%. The method is useful in the quality control of bulk manufacturing.
authors.affiliation: Analytical Research, SMS Pharma Research Center, C-23, IE, Sanathnagar, Hyderabad, Andhra Pradesh 500 018, India.
authors.forename: A Phani
authors.initials: AP
authors.lastname: Kumar
authors.forename: V R L
authors.initials: VR
authors.lastname: Ganesh
authors.forename: D V Subba
authors.initials: DV
authors.lastname: Rao
authors.forename: C
authors.initials: C
authors.lastname: Anil
authors.forename: B Venugopala
authors.initials: BV
authors.lastname: Rao
authors.forename: V S
authors.initials: VS
authors.lastname: Hariharakrishnan
authors.forename: A
authors.initials: A
authors.lastname: Suneetha
authors.forename: B Syama
authors.initials: BS
authors.lastname: Sundar
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D014363:Tryptamines / Q000032:analysis*
chemical_list: D014363:Tryptamines; C409045:almotriptan