Abstract
OBJECTIVE To establish a HPLC quantitative method for the determination of imipenem and cilastatin sodium for Injection.METHODS The separation was performed on a CN column(4.6 mm×250 mm,5μm) with mobile phase of acetonitrile -0.1%phosphoric acid(50:50) at the flow rate of 1 mL·min-1.The determination wavelength was at 265 nm.The column temperature was at 30℃.RESULTS The theoretical plate number of imipenem was 9 000,and that of cilastin sodium was 9 500.The resolution was more than 1.5.The regression equation for imipenem was Y=0.638 6X+6.173(r=0.999 9),and the linear range was 117.1-585.5 mg·L-1.The regression equation of cilastin sodium was Y=0.588 6X+6.294(r=0.999 9),and the linear range was 117.1-585.3 mg·L-1.The average recoveries of imipenem and cilastin sodium were 98.8%(1.7%) and 99.2%(1.1%), respectively.CONCLUSION The method is precise,accurate,simple,and can be applied to determin the content of Imipenem and Cilastin Sodium for Injection.
Key words
HPLC /
imipenem /
cilastin sodium
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LIU Gng;ZHOU Qin-yi;LI Jin-li;LN Qing;JING Ren;ZHNG Hu;TN Sheng-jin.
Determination of Imipenem and Cilastatin for Injection Sodium by HPLC [J]. Chinese Pharmaceutical Journal, 2009, 44(10): 787-789
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References
[1] USP29 [S]. 2006: 1110-1111.
[2] State Food and Drug Administration Standards for Imported Drug Registration,Standard No[S].:JX20060135.
[3] WU X H,WANG M J,HU C Q. Content determination and content uniformity of imipenem and cilastatin sodium for injection by HPLC[J]. J Chin Antibiot(中国抗生素杂志),2005,30(10):591-593.
[4] LIU H,WANG H W,QIU S L. Study of peak profile of carbapenem antibiotics in HPLC Ⅱ. Peak broadening and splitting of impenem[J]. J Chin Antibiot(中国抗生素杂志),2003,28(8):468-471.
[5] KAN J Y,XU W. Investigation of the compatible stability of imipenem and cilastatin sodium for injection in five injections [J]. Chin J Pharm Anal(药物分析杂志),2006,26 (3): 390-394.
[6] KAN J Y. Investigation of the compatible stability of imipenem and cilastatin sodium for injection in five injections [J]. Anhui Med Pharm J(安徽医药),2007,11 (12):1071-1072.
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