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  • Title: A validated reversed phase HPLC method for the determination of process-related impurities in almotriptan malate API.
    Author: Kumar AP, Ganesh VR, Rao DV, Anil C, Rao BV, Hariharakrishnan VS, Suneetha A, Sundar BS.
    Journal: J Pharm Biomed Anal; 2008 Mar 13; 46(4):792-8. PubMed ID: 18191357.
    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.
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