HPLC法分析注射用普鲁卡因青霉素有关物质

目的:建立高效液相色谱检测法分析注射用普鲁卡因青霉素有关物质.方法:采用汉邦C18色谱柱,以缓冲液取磷酸二氢钾14 g和40%氢氧化四丁基铵溶液6.5 g溶解于约700 mL水中,用1 mol·L-1氢氧化钾溶液或10%稀磷酸溶液调节pH至7.0,用水稀释至1 000 mL,混匀]-水-乙腈(500:250:250)为流动相,流速为1.0 mL·min-1,检测波长为225 nm.结果:普鲁卡因、青霉素和杂质在此色谱条件下分离良好.结论:方法快速、简便,结果准确可靠,重复性好,可用于注射用普鲁卡因青霉素的质量控制.

Determination of Related Substances in Procaine Benzylpenicillin for Injection by HPLC

Objectives: To develop a new and simple HPLC method for determination of related substances in Procaine Benzylpenicillin for Injection.Methods: A Hanbon C₁₈ column was used.Detecting wavelength was 225 nm.The mobile phase consisted of 250 volumes of acetonitrile,250 volumes of water and 500 volumes of a freshly prepared buffer solution(containing 14g·L^-1 of potassium dihydrogen orthophosphate and 6.5 g·L^-1 of 40% tetrabutylammonium hydroxide solution,adjusted to pH 7.0 with 1 mol·L^-1 potassium hydroxide or 10% phosphoric acid solution)with flow rate of 1 mL·min^-1.Results: Good separation of procaine,benzylpenicillin and main related substances was achieved.Conclusions: The results showed that the method was simple,sensitive and practicable for determination of related substances in Procaine Benzylpenicillin for Injection.