RP-HPLC梯度洗脱法测定盐酸伊托必利的有关物质

目的: 建立RP-HPLC梯度洗脱法测定盐酸伊托必利的有关物质。 方法: Alltima C₁₈ 柱(4.6 mm×250 mm,5 μm);流动相为0.05 mol·L^-1 磷酸二氢钾溶液(调节pH至4.0)-乙腈进行梯度洗脱,流速1.0 mL·min^-1,柱温35℃,检测波长258 nm,进样量20 μL。 结果: 本文色谱条件中盐酸伊托必利与杂质有较好分离,盐酸伊托必利浓度在1~10 μg·mL^-1 范围内与峰面积线性关系良好 (r=0.9999,n=5),最低检测限为6 ng。 结论: 本法简便、专属,重复性好,可用于测定盐酸伊托必利的有关物质。

Objective: To establish an RP-HPLC method for determining the related substances of itopride hydrochloride. Methods: Alltima C₁₈ column (4.6 mm×250 mm,5 μm) was adopted with the mobile phase consisting of 0.05 mol L^-1 potassium dihydrogen phosphate (pH:4.0)-acetonitrile at the flow rate of 1.0 mL·min^-1.The column temperature was 35℃.The UV detection wavelength was set at 258 nm.The injection volume was 20 μL. Results: Under the above conditions,itopride hydrochloride and its related substances were separated quite well.Itopride hydrochloride had a good linear relationship (r=0.9999,n=5) with the peak area within the range of 1-10 μg·mL^-1.The minimal limit of detection was 6 ng. Conclusion: The method is simple and specific with great repeatability and can be used for determining the related substances of itopride hydrochloride.

1 DU Wen-shuang(杜文双).Itopride hydrochloride,a new gastrointestinal prokinetic agent (新型胃动力药——盐酸伊托必利).Her Med (医药导报),2003,22(7):490
2 Iwanaga Y,Miyashita N,Saito T.Gastroprokinetic effect of a new benzamide derivative itopride and its action mechanisms in conscious dogs.Japan J Pharmacol, 1996,66:129
3 Formal approval standards for new drugs,P R China(中华人民共和国新药转正标准).Vol.53(第五十三册):139
4 Neeraj K,Himani A,Pravin M.Chromatographic determination of itopride hydrochloride in the presence of its degradation products. J Sep Sci,2005,28(13):1566
5 Suganthi A,John S,Ravi TK.Simultaneous HPTLC determination of rabeprazole and itopride hydrochloride from their combined dosage form. Indian J Pharm Sci,2008,5(6):366
6 YANG Li-hong(杨利红),HU Chang-qin(胡昌勤),LIU Wen-ying(刘文英).HPTLC determination of gentamicin and its related substances (HPTLC法测定庆大霉素组分及其相关物质).Chin J Pharm Anal(药物分析杂志),2006,2(2):221