The Quality Control Research Of Gemcitabine Hydrochloride And Gemcitabine Hydrochloride For Injection

Gemcitabine Hydrochloride, (+)2'-deoxy-2',2'-difluorocytidinemon ohydrochloride, It has played an important role in the treatment of various cancers, and has a broad-spectrum antitumor effect. It has shown encourage activity in a wide range of tumors, including non-small-cell lung cancer, breast cancer, pancreatic cancer, etc. Gemcitabine Hydrochloride has definite anticancer effect and is one of the preferred treatment of non-small-cell lung cancer.,and also is the first choice of pancreatic cancer chemotherapy. It is a safe and effective anti-cancer drug, and has great prospects in clinical applications.According to the request of (the Guidelines for the chemical medicine quality research), (the quality standard of Gemcitabine Hydrochloride) (WS1-(X-448)-2003Z), (the quality standard of Gemcitabine Hydrochloride) (USP 30)and(the Guidelines for the Analytical Method Validation of the drug quality standard) (China Pharmacopoeia, Part 2 (2005 edition), Appendix XIX), experiment to the quality control method of Gemcitabine Hydrochloride and Gemcitabine Hydrochloride for Injection.Scientific experiments were established at the chemical structure characteristic and manufacturing technique of Gemcitabine Hydrochloride. The study was emphasized on character, indentification, tests and assay. Physics and chemistry constants such as appearance, solubility, acidity and specific rotation were tested. HPLC methods were established for determination of assay and related substances.Residual of organic solvents were tested by capillary GC method.The analysis methods were studied and validated according to the ICH guidance. The methods were proved to be accurate and reliable with high selectivity, sensitivity and reproducibility, and were suitable for the quality control of Gemcitabine Hydrochloride and Gemcitabine Hydrochloride for Injection.According to the request of (the Guidelines for the chemical medicine stability research), experiment to the stability of Gemcitabine Hydrochloride and Gemcitabine Hydrochloride for Injection. The influence factors of stability of Gemcitabine Hydrochloride and Gemcitabine Hydrochloride for Injection are inspected by influence factor test, accelerated test and long-term test. At the same time, period of validity of drug is determined.The quality standards established by the research can reflect drug'production techniques and quality, which providing efficient analysis methods and standards for Gemcitabine Hydrochloride and Gemcitabine Hydrochloride for Injection.