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Information Journal Paper

Title

Enantioselective Box Behenken Optimized HPLC-DAD Method for the Simultaneous Estimation of Alogliptin Enantiomorphs in Pharmaceutical Formulations and their Pharmacokinetic Study in Rat Plasma

Pages

  147-158

Abstract

 Purpose: A stereoselective high performance liquid chromatographic analytical method with photodiode array detector was developed and validated as per the International Conference on Harmonization (ICH) guidelines for the determination of alogliptin (ALO) enantiomers in formulations and rat plasma. Methods: Enantiomeric separation was performed on a Phenomenex Lux Cellulose-2 chiral column. Box-Behnken design was used to identify the optimum conditions of the three independent variables for the desired output responses. Results: The HPLC peaks of ALO enantiomers and the internal standard pioglitazone were achieved before 8 min with a resolution of 0. 77 min between R and S enantiomer and resolution of more than 2. 0 between each enantiomer and pioglitazone (internal) with more than 95% recovery. The linearity range and the limit of quantification of both the enantiomers in rat plasma were 10-70 ng mL-1 and 1. 2 ng mL-1 reSPEctively. Conclusion: The developed method after validation was successfully applied for estimation of ALO enantiomers in formulations. Single oral dose of 25 mg of the ALO racemate tablets were administered to a group of 6 healthy rats for a comparative pharmacokinetic study of both the enantiomers.

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  • Cite

    APA: Copy

    Kant, Ravi, Bodla, Ramesh Babu, Bhutani, Rubina, & Kapoor, Garima. (2019). Enantioselective Box Behenken Optimized HPLC-DAD Method for the Simultaneous Estimation of Alogliptin Enantiomorphs in Pharmaceutical Formulations and their Pharmacokinetic Study in Rat Plasma. ADVANCED PHARMACEUTICAL BULLETIN, 9(1), 147-158. SID. https://sid.ir/paper/745879/en

    Vancouver: Copy

    Kant Ravi, Bodla Ramesh Babu, Bhutani Rubina, Kapoor Garima. Enantioselective Box Behenken Optimized HPLC-DAD Method for the Simultaneous Estimation of Alogliptin Enantiomorphs in Pharmaceutical Formulations and their Pharmacokinetic Study in Rat Plasma. ADVANCED PHARMACEUTICAL BULLETIN[Internet]. 2019;9(1):147-158. Available from: https://sid.ir/paper/745879/en

    IEEE: Copy

    Ravi Kant, Ramesh Babu Bodla, Rubina Bhutani, and Garima Kapoor, “Enantioselective Box Behenken Optimized HPLC-DAD Method for the Simultaneous Estimation of Alogliptin Enantiomorphs in Pharmaceutical Formulations and their Pharmacokinetic Study in Rat Plasma,” ADVANCED PHARMACEUTICAL BULLETIN, vol. 9, no. 1, pp. 147–158, 2019, [Online]. Available: https://sid.ir/paper/745879/en

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