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  • Chem Sci Trans., 2018, 7(3),  pp 506-514  

    DOI:10.7598/cst2018.1492

    Research Article

    Development and Validation of Chiral HPLC Method for the Identification and Quantification of Enantiomer in Posaconazole Drug Substance

  • CHERUKURU NAGARAJU1,2,*, UTTAM KUMAR RAY1 and SIDDAIAH VIDAVALUR2
  • 1APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71 and 72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad-502 329, Telangana, India
    2Department of Organic Chemistry and FDW, Andhra University, Visakhapatnam-530 003, Andhra Pradesh, India
  • Abstract

    A simple and sensitive normal phase isocratic high performance liquid chromatographic method was developed for the determination of trace level enantiomer in posazonazole drug substance. The separation was achieved using chiral pack, IC, 250 x 4.6 mm, 5 ?m using mobile phase containing isopropyl alcohol, dichloro methane and diethyl amine (50:50:0.1 v/v/v). The flow rate was 0.6 mL/min and column temperature was 25 ?C. Enantiomer was detected using UV detector at the wave length 262 nm. The retention time was 18.5 min for enantiomer and 28 min is for posaconazole. The optimized method was validated to prove its performance characteristic by demonstrating selectivity, sensitivity (Limit of detection and Limit of quantification), linearity, precision and accuracy. The limit of detection and limit of quantification of ennatiomer was found to be 0.06 μg/mL and 0.2 μg/mL for 10 μL injection volume. The linearity of the method is found to be 0.2 μg/mL to 1.5 μg/mL. Relative standard deviation of system precision, method precision is found to be 0.3% and 0.44% respectively. The accuracy of the method is found to be 96.0% to 98.1%.

    Keywords

    HPLC, Chiral chromatography, Normal phase, Posaconazole, Validation

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