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Development and validation of a stability-indicating liquid chromatographic method for determination of emtricitabine and related impurities in drug substance

✍ Scribed by Unnam Seshachalam; Bodepudi Haribabu; Kottapalli B. Chandrasekhar

Publisher
John Wiley and Sons
Year
2007
Tongue
English
Weight
900 KB
Volume
30
Category
Article
ISSN
1615-9306

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✦ Synopsis

Abstract

A novel stability‐indicating high‐performance liquid chromatographic (HPLC) method was developed and validated for assay and determination of impurities of emtricitabine in drug substance. Emtricitabine was found to be degraded under acidic, alkaline, and oxidative stress conditions and to be more labile under oxidative conditions. The drug proved to be stable to dry heat and photolytic degradation. Resolution of major and minor degradation impurities was achieved on an Intersil ODS‐3V column utilizing 10 mM sodium phosphate buffer and methanol (85:15) as mobile phase. Detection was at 280 nm. Validation studies were performed as per ICH recommended conditions. The developed method was found to be linear, accurate, specific, selective, precise, and robust.

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