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A Validated Reversed Phase HPLC Method for the Determination of Process-Related Impurities in Almotriptan Malate API

A Validated Reversed Phase HPLC Method for the Determination of Process-Related Impurities in Almotriptan Malate API

A Phani Kumar, V R L Ganesh, D V Subba Rao, C Anil, B Venugopala Rao, V S Hariharakrishnan, A Suneetha, B Syama Sundar

J Pharm Biomed Anal. 2008 Mar 13;46(4):792-8.

PMID: 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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP334981123	Almotriptan Related Compound C		334981-12-3	Price

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