Development and validation of a high-performance size-exclusion chromatography method for polymer determination in cefmetazole sodium for injection

• Autorzy: Zhong J. , Chen Y. C. , Liu X. Y.

Identyfikatory

DOI

10.1556/1326.2017.29.2.4

• Języki publikacji: EN

Abstrakty

EN

This study aims to develop and validate a high-performance size-exclusion chromatography (HPSEC) method to determine the amount of polymer in cefmetazole sodium for injection and to compare this method with gel chromatography. A Zenix SEC-150 column was used with the mobile phase of phosphate buffer solution (pH 7.0; 0.01 M)—acetonitrile (90:10 v/v) at a flow rate of 0.8 mL min−1 and a detection wavelength of 240 nm. The polymer was quantified by an external standard method with self-control, and the amount was expressed by the percentage of cefmetazole. The HPSEC method was validated for specificity, linearity, and precision. The chromatographic conditions, chromatographic performances, sensitivity, linearity, and precision of the developed HPSEC method and gel chromatography were compared, and both methods were subsequently used to determine the amount of polymer from seven batches of samples. The HPSEC method was fully validated. The time of isocratic elution for sample assay was less than 14 min. The results of comparison indicate that the developed HPSEC method was superior to gel chromatography. The Student t test results also showed significant difference in the amount of polymer from the samples obtained by the two methods. Thus, the HPSEC method with two obvious advantages, the superior sensitivity and a shorter analysis time, is more suitable for determination of polymer amount in cefmetazole sodium for injection to control the quality of the product.

Słowa kluczowe

EN

HPSEC; gel chromatography; polymer; cefmetazole

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2017
• Tom: Vol. 29, no. 2
• Strony: 193--205
• Opis fizyczny: Bibliogr. 14 poz., rys.

Twórcy

autor

Zhong J.

• Department of Pharmacy, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi 214002, China

autor

Chen Y. C.

• Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai 200040, China

autor

Liu X. Y.

• Department of Chemistry, the Institute for Drug Control of Wuxi, Wuxi 214000, China

Bibliografia

• [1] S. Nakagawa, H. Hisada, N. Nomura, J. Mitsuyama, S. Matsubara, K. Watanabe, Y. Asano, H. Suematsu, H. Sawamur, H. Hashido, Y. Yamagishi, H. Mikamo, and Y. Matsukawa, Jpn. J. Antibiot., 66, 251–264 (2013)
• [2] A. Doi, T. Shimada, S. Harada, K. Iwata, T. Kamiya, K. Iwata, and T. Kamiya, Int. J. Infect. Dis., 17, 159–163 (2013)
• [3] J. Shimizu, K. Ikeda, M. Fukunaga, K. Murata, A. Miyamoto, K. Umeshita, T. Kobayashi, and M. Monden, Surg. Today, 40, 954–957 (2010)
• [4] W.J. Holloway, D.L. Winslow, and J.F. Reinhardt, J. Antimicrob. Chemother, 23 Suppl D, 47–54 (1989)
• [5] E. L. Miller, J. Midwifery Women’s Health, 47, 426–434 (2002)
• [6] M. Iwata, H. Tokiwa, and T. Matuhasi, Int. Arch. Allergy. Appl. Immunol., 70, 132–137 (1983)
• [7] C. Hu, S. Jin, and K. Wang, J. Pharm. Biomed. Anal., 12, 533–541 (1994)
• [8] Y.C. Shan, Q.H. Chang, and Z.X. Ming, J. Pharm. Biomed. Anal., 31, 589–596 (2003)
• [9] Y.L. Ding, W.G. Du, R. Cai, and X.J. Huang, J. Guangdong Pharm. Univ., 28, 526–528 (2012)
• [10] SEC, Zenix®, http://www.sepax-tech.com.cn/products/tjpz1/tjpz/SEC/2.html
• [11] China Pharmacopoeia Committee, China Pharmacopoeia, China Medical Science Press, Beijing, 2010, Vol. II: appendix VH38
• [12] China Pharmacopoeia Committee, China Pharmacopoeia, China Medical Science Press, Beijing, 2010, Vol. II: appendix VH37
• [13] China Pharmacopoeia Committee, China Pharmacopoeia, China Medical Science Press, Beijing, 2010, Vol. II: appendix VD30
• [14] China Pharmacopoeia Committee, China Pharmacopoeia, China Medical Science Press, Beijing, 2010, Supplement II: 216.

Uwagi

PL

Opracowanie ze środków MNiSW w ramach umowy 812/P-DUN/2016 na działalność upowszechniającą naukę (zadania 2017).