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Chiral Separation of Carboprost Isomers by Normal Phase LC Using Amylose Chiral Stationary Phase

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Abstract

LC separation of carboprost diastereomers in bulk drug was developed and validated using normal-phase amylose stationary phase Chiralpak AD-H. The effect of the organic modifiers, namely 2-propanol and ethanol in the mobile phase was optimized in order to obtain the best separation. The retention time of (R)-carboprost and (S)-carboprost were 15.3 and 17.1 min, respectively. Calibration curves were linear over the range of 0.2–1.0%, with the regression coefficient (R 2) of 0.9997. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.07 and 0.2%, respectively. The method was accurate, precise and suitable to use for the purpose of controlling unwanted (R)-isomer in the carboprost active pharmaceutical ingredient. This method can be successfully applied to the analysis of chiral purity of carboprost in pharmaceutical bulk drug samples.

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Authors and Affiliations

  1. DOS in Chemistry, University of Mysore, Manasagangothri, Mysore, 570006, India

    S. G. Hiriyanna & K. Basavaiah

  2. Department of Analytical Chemistry, Advinus Therapeutics Pvt. Ltd, Peenya II Phase, Bangalore, 560058, India

    V. Dhayanithi & H. N. Pati

Authors
  1. S. G. Hiriyanna
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  2. K. Basavaiah
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  3. V. Dhayanithi
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  4. H. N. Pati
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Correspondence to S. G. Hiriyanna.

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Hiriyanna, S.G., Basavaiah, K., Dhayanithi, V. et al. Chiral Separation of Carboprost Isomers by Normal Phase LC Using Amylose Chiral Stationary Phase. Chroma 68, 501–505 (2008). https://doi.org/10.1365/s10337-008-0742-z

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  • DOI: https://doi.org/10.1365/s10337-008-0742-z

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