ABSTRACT
Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets by near infrared reflectance(NIR) spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respectively to pretreat the corresponding NIR spectra of aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000~4000 cm-1. The optimum modeling band were 9000-7500cm-1, 6900-5600 cm-1and 5000-4250 cm-1, respectively, and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentic ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments, realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclusion The conformity test model is accurate, simple, feasible, and suitable for the drug examination of zidovudine film-coated tablets.
ABSTRACT
Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus (HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be produced by local drug producers in some countries. Therefore, new methods are required to control sofosbuvir in pharmaceuticals. In the present study, a new method based on reversed phase (RP)-ultra-high performance liquid chromatography (UHPLC) coupled to diode array detection (DAD) and mass spectrometry (MS) was developed to facilitate the qualitative and quantitative analysis of sofosbuvir in film coated tablets. A wavelength of 260 nm was selected to perform a cost-effective quantification and the method showed adequate linearity, with an R2 value of 0.9998, and acceptable values of accuracy (75%–102%) and precision (residual standard deviation < 5%). The detection and quantification limits were 0.07 μg/mL and 0.36 μg/mL, respectively. Furthermore, the use of high-resolution MS enabled us to ensure the specificity, check impurities and better sensitivity. Therefore, this methodology promises to be suitable not only for the routine analysis of sofosbuvir in pharmaceutical dosage forms, but also for potential degradants.
ABSTRACT
Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets by near infrared reflectance(NIR)spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respectively to pretreat the corresponding NIR spectra of aluminum-plastic pack?age and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000~4000 cm-1. The optimum modeling band were 9000-7500cm-1,6900-5600 cm-1and 5000-4250 cm-1,respectively,and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentic ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments,realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclu?sion The conformity test model is accurate,simple,feasible,and suitable for the drug examination of zidovudine film-coated tablets.
ABSTRACT
OBJECTIVE:To prepare film-coated Chenxianglubailu tablet and to improve its stability.METHODS:The core of the film-coated tablet was prepared with different cohesives;which were then coated with different coating substances.The stability of film-coated Chenxianglubailu tablet and that of the coated tablet were compared.RESULTS:The film-coated Chenxianglubailu tablet,with its tablet core made from10%polyvidone alcohol solution,which was protected by an insulation substance zein,which was prepared by gastric soluble yellow or marron coating power from Shanghai Colorcon Company was superior to other preparations made from other materials in appearance and quality,particularly in its oil-ooz?ing-proof and moisture-proof properties.The stability of film-coated tablet was superior to that of the sugar coated tablet.CONCLUSION:The film-coated Chenxianglubailu tablet is stable in quality and its preparation is simple.
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OBJECTIVE: To study the preparation of Jingluoning film-coated tablets. METHODS: The preparation of Jingluoning film-coated tablets was optimize by single factor method with granule characteristics, distribution of particle size, angle of repose, surface finish, rigidity and disintegration time limit as index. RESULTS: The optimal preparation method was as follows: the weight proportion of dry extraction to starch, dextrin and silica powder was 16.7 ∶ 16 ∶ 3 ∶ 1; the wetting agent was 90% alcohol; qualified tablets were prepared through wet granulation, tablet compressing and film coating. CONCLUSION: The preparation method is simple and practical. Prepared tablets were characterized with light weight, fast disintegration, low moisture content and good appearance and their quality is in line with the tablet general requirements stated in Chinese Pharmacopoeia (2005 edition).
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Objective:To investigate the quality of Naosaitong Tablets by determing of the dissolution rates of different batches of tablets. Methods: The rotatory-basket method was used. The cumulative dissolution percentage was determined by UV. The dissolution parameters were got and their correlation was studied. Results: Statistics indicated there was a significant difference in dissolution parameter (T 50) between film-coated tablets and sugar-coated tablets. The dissolution percentage of film-coated tablets in 45 minutes was over 90%, whereas sugar-coated tablets was only 49-78%. Conclusion: Niaosaitong Film-coated Tablets in superior to its sugar-coated tablets in dissolution rate. It is necessary to improve the quality of Niaosationg Sugar-coated Tablets.