Comparative Study On Quality Of Cefpodoxime Proxetil & Quantitative Analysis Of Its Dry Suspensions By Near-Infrared Spectrometry

Cefpodoxime Proxetil is one of the third generation broad-spectrum orally administered cephalosporins, which was developed by Sankyo Co., Ltd. Tokyo, Japan and launched into the market in 1990. In the past several years, the dosage form of the drug has changed and improved increasingly. As a result, Cefpodoxime Proxetil Dry Suspensions is going to be marketed in China soon following its tablets and capsules. Within the same period, the number of drug substance manufactures of Cefpodoxime Proxetil has also increased rapidly, and then there are more and more products manufactured by different foreign and domestic pharmaceutical companies beside its innovator company in the present market.In order to have quality of the drug under control to ensure its safety and efficiency, comparative study and evaluation on Cefpodoxime Proxetil drug substance as well as its dry suspensions were carried out in this thesis. With that, some basic but meaningful researches on the application of the advanced and promising Near-Infrared Spectroscopy analytical technology to the quantitative analysis of Cefpodoxime Proxetil Dry Suspensions were conducted. Four primary results in this thesis are as follows.A RP-HPLC method for determination of Cefpodoxime Proxetil and its related substances under the same chromatographic conditions were developed and validated, and a new method to improve the system suitability test recorded in "The Minimum Requirements for Antibiotics of Japan" and USP26 by using in situ degradation was put forward.Aimed at related substances and residual solvents, quality of the imported Cefpodoxime Proxetil drug substances and that of the native ones were compared and evaluated, and with the application of "A Knowledge Base for Prescreening Residual Solvents in Pharmaceuticals " and GC-IR associated with GC-MS, some kinds of unknown residual solvents in a batch of sample were identified.The stability test of Cefpodoxime Proxetil Dry Suspensions in two different types of package forms was performed and the influence of package form on the stability of the drug was studied.A Near-Infrared Spectroscopy (NIR) quantitative analysis model for Cefpodoxime Proxetil Dry Suspensions was established and a variety of further studies on possible questions and influence factors in the establishment of quantitative analysis model for dry suspensions were conducted.