| Literature DB >> 18191357 |
A Phani Kumar1, V R L Ganesh, D V Subba Rao, C Anil, B Venugopala Rao, V S Hariharakrishnan, A Suneetha, B Syama Sundar.
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.Entities:
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Year: 2007 PMID： 18191357 DOI： 10.1016/j.jpba.2007.11.029
Source DB: PubMed Journal: J Pharm Biomed Anal ISSN： 0731-7085 Impact factor: 3.935