Studies On The Preparation And Quality Standard Of Zidovudine And Lamivudine Tablets

Objective Based on the chinese pharmacopoeia 2010 as the basis(The Chinese pharmacopoeia 2015 was started in December 1,2015),through prescription screening test to determine the complete prescription of Zidovudine and Lamivudine Tablets.This study through the quality standard of the Zidovudine and Lamivudine Tablets research method and system validation,established the scientific and complete quality inspection method.Method:(1)Study on Preparation Technology: The effects of the thinner,the disintegration and the bond to the in vitro dissolution of Zidovudine and Lamivudine Tablets were studied;With the dissolution rate,smooth faces,uniform colour,appropriate rigidity,low smash ratio,little fluctuate of tablet weight and short breakdown time as index,the quality standard of Zidovudine and Lamivudine Tablets was investigated.(2)Quality standard studies: Dissolution of Zidovudine and Lamivudine Tablets was determined by ultraviolet spectrophotometry,and detection wavelength was set at 266nm/286 nm.The content of Zidovudine and Lamivudine Tablets was determined by high performance liquid chromatography(HPLC),the separation between zidovudine and lamivudine was performed on a Cosmosil ODSC18column(4.6×250mm,5μm),With 0.025mol/L ammonium acetate solution(p H4.0+0.1)as mobile phase A,methanol as mobile phase B,acetonitrile as mobile phase C,flow rate: 0.5m L/min,detection wavelength: 270 nm.(3)Preliminary stability study:Preliminary stability study was performed,in accordance with the quality standards of Zidovudine and Lamivudine Tablets.Result(1)The optimized formulation was composed of Zidovudine 300 g,lamivudine 150 g,microcrystalline cellulose 90 g,sodium carboxymethyl starch 32 g,magnesium stearate 8g,colloidal silicon dioxide 8g and 3% low substituted hydroxypropyl cellulose.The optimum process is obtained through experiments,and microcrystalline cellulose,sodium carboxymethyl starch,magnesium stearate and Silicii Doxydum were screened through mesh size of 80,Zidovudine,Lamivudine and1/3 sodium carboxymethyl starch,mix.Made of soft material by 3%low substituted hydroxypropyl cellulose,pelleting,passed through the 20 mesh screen for granulation,drying by 50℃ and through the 20 mesh screen.Add the amount of magnesium stearate,microcrystalline cellulose and the remaining 2/3 sodium carboxymethyl starch,mixing and tableting.(2)Dissolution studies illustrated that the linear range of zidovudine was1.69-20.28μg/m L,and the correlation coefficient r was 0.999,the average recovery of zidovudine was 101.46% and the RSD was 0.70%;the linear range of lamivudine was0.785-9.42μg/m L,and the correlation coefficient r was 0.999,the average recovery of lamivudine was 98.60% and the RSD was 0.37%.The content results showed that the linear range of zidovudine and lamivudine were 0.024-0.12mg/m L,0.0096-0.0768mg/m L,and the correlation coefficient r was 0.9999 and 0.9998,the average recovery of zidovudine and lamivudine were 99.69% and 98.20% and the RSD were 0.93% and0.63%.(3)The stability of three batches samples were shown that the quality of the sample was stable and no significant effect was found.Conclusion Research showed that Zidovudine and Lamivudine Tablets’ s process route is short,simple operation,low cost,less pollution,reasonable production process,quality control standard and feasible.The inspection result of the three batches of samples were qualified,indicated that the prescription and preparation process for the production of Zidovudine and Lamivudine Tablets quality conforms to the national pharmacopoeia standard.Through accelerated test and long-term test,to determine the validity of the product and storage conditions in this study,and indicated that the product should be stored in the shade.At the same time,it is clear that the quality of the goods in a reasonable storage conditions,a certain period of quality indicators were not changed significantly,which could realize the industrialization production.