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Development and validation of a stability‐indicating liquid chromatographic method for determination of emtricitabine and related impurities in drug substance
Author(s) -
Seshachalam Unnam,
Haribabu Bodepudi,
Chandrasekhar Kottapalli B.
Publication year - 2007
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200600429
Subject(s) - chromatography , chemistry , emtricitabine , forced degradation , high performance liquid chromatography , methanol , impurity , degradation (telecommunications) , drug , reversed phase chromatography , organic chemistry , pharmacology , medicine , telecommunications , family medicine , human immunodeficiency virus (hiv) , viral load , antiretroviral therapy , computer science
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.