Reversed‐phase chiral high‐performance liquid chromatography method for separation of abacavir sulfate enantiomer in drug substance. Issue 11 (19th October 2020)

• Record Type: Journal Article
• Authors: Ramesh, Ch.; Rama devi, Dharmasoth; Srinivas, MNB.; Rajana, Nagaraju; Krishna, S. Radha; Basavaiah, K.
• Is Part Of: Separation science plus. Volume 3:Issue 11/12(2020)
• Page Start: 553
• Page End: 560
• Publication Date: 2020-10-19
• Subjects: abacavir sulfate -- enantiomer -- reversed phase‐chiral high‐performance liquid chromatography -- validation; Chromatographic analysis -- Periodicals; 543.8
• DOI: 10.1002/sscp.202000080
• Languages: English
• ISSNs: 2573-1815

Abstract

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.