Premium
Reversed‐phase chiral high‐performance liquid chromatography method for separation of abacavir sulfate enantiomer in drug substance
Author(s) -
Ramesh Ch.,
Rama devi Dharmasoth,
Srinivas MNB.,
Rajagaraju,
Krishna S. Radha,
Basavaiah K.
Publication year - 2020
Publication title -
separation science plus
Language(s) - English
Resource type - Journals
ISSN - 2573-1815
DOI - 10.1002/sscp.202000080
Subject(s) - chromatography , chemistry , enantiomer , abacavir , detection limit , high performance liquid chromatography , organic chemistry , hepatitis b virus , virus , virology , lamivudine , biology
Abstract For separation of abacavir sulfate enantiomers, normal phase chiral methods were reported. Handling of normal phase solvents for high‐performance liquid chromatography is very difficult in quality control laboratories and also no reversed phase‐chiral high‐performance liquid chromatography method for separation of abacavir sulfate enantiomer in drug substance has been reported. A new and accurate isocratic reversed phase‐chiral high‐performance liquid chromatography method was developed and validated for the separation of abacavir sulfate undesired enantiomer in abacavir. The separation achieved on amylose derivative chiral column, i.e. chiralpak AD‐H containing amylose tris‐3,5‐dimethyl phenyl carbamate using 0.1% triethylamine in a mixture of water, methanol, and acetonitrile as a mobile phase. The correlation coefficient values were 0.998 and 0.997 for the undesired enantiomer and the desired enantiomer of abacavir sulfate, respectively. The limit of detection was 0.01% and the limit of quantification was 0.03%. The precision enantiomer at limit of quantification level was evaluated through six replicate injections and the relative standard deviation of the peak response achieved is 2.5. The percentage recoveries of undesired enantiomer from abacavir sulfate drug substance were from 96.7 to 118.0%. The drug substance was subjected to stress studies. It was found to not degrade significantly under acidic, hydrolysis, and oxidative stress conditions.