A validated chiral LC method for the enantiomeric separation of repaglinide on immobilized amylose based stationary phase

Journal of the Brazilian Chemical Society

Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, India¹  Yeole, Ravindra¹  Rane, Vipul¹  Patil, Kiran¹  Wockhardt Research Centre, Aurangabad, India¹  Shinde, Devanand¹ 

关键词: repaglinide;    enantiomeric purity;    chiral LC;    method validation;   

DOI  :  10.1590/S0103-50532012000600008

学科分类：化学（综合）

来源: SciELO

【 摘 要 】

A simple, rapid, isocratic, normal phase chiral HPLC method was developed and validated for the enantiomeric separation of repaglinide, (S)-(+)-2-ethoxy-4-N [1-(2-piperidinophenyl)-3-methyl-1-butyl] aminocarbonylmethyl] benzoic acid, an antidiabetic drug substance. The enantiomers of repaglinide were resolved on a Chiralpak IA (immobilized amylose based stationary phase) column using a mobile phase consisting of n-hexane:ethanol:trifluoroacetic acid (80:20:0.2, v/v/v) at a flow rate of 1.0 mL min-1. The resolution between both enantiomers was greater than 2 in the optimized method. The developed method was extensively validated and proved to be robust, enantioselective, accurate, precise, and suitable for quantitative determination of (R)-enantiomer in bulk drug substance and product.

【 授权许可】

Unknown