| Partâ… Analysis method establishment of the determination of Aminophylline and Methylprednisolone by HPLCObjective:Chromatographic separation conditions of aminophylline and methylprednisolone were groped,to develop a sensitive,accurate and simple High Performance Liquid Chromatography Assay(HPLC) for the quantitative analysis.Method:HPLC for the determination of aminophylline and methylprednisolone sodium succinate was performed,using Waters 600-2996-717 system on a Xterra RPC18 (4.6×150mm,5μm) column,with the mobile phase of methanol:0.01mol.L-1 dibasic sodium phosphate buffer solution(pH=3.0),gradient elution,at the dectective wavelength of 246.5nm,with the flow rate of 1.0 mL·min-1,column temperature at 25℃.According to the chromatographic conditions,sampling the reference mixture,chromatographic charts of aminophylline,succinate methylprednisolone and free methylprednisolone were recorded;RSD%of inter-day,within-day precision and recovery was calculated respectively.Result:The retention time of aminophyllyine,succinate methylprednisolone and free methylprednisolone was 3.5,19.5 and 18.1min respectively;RSD%of inter-day precision was 0.33%,0.55%and 1.93%respectively,RSD%of within-day precision was 1.01%,1.65%and 2.76%respectively;RSD%of recovery of aminophyllyine and succinate methylprednisolone was 0.25%,1.17%respectively,accepted by relative standard.Conclusion:This method is sensitive,accurate and simple for determination of aminophylline and methylprednisolone.Partâ…¡Compatibile Stability Study of Aminophylline for Injection and Methylprednisolone Sodium Succinate for InjectionObjective:To study the compatible stability of aminophylline for injection and methylprednisolone sodium succinate for injection in 5%glucose injection.Method:Determine pH values of the sample mixture within 8h,observing external appearance,whether the mixture had gas production,turdibity and precipitation or not; and determining the content of mixture.Result:There were no significant changes in pH values and external appearance for mixture,there were no gas production,no turdibity and precipitation at room temperature in 8h.the content changes of mixture were also not significant within 8h.Conclusion:The mixture of aminophyllyine for injection and methylprednisolone sodium succinate for injection in 5%giucose injection kept relative stability within 8h. Partâ… Analysis method establishment of the determination of Ethylenediamine Diaceturate and Vitamin C by dual-wavelength Ultraviolet SpectrophotometryObjective:To develop a rapid,accurate and simple dual-wavelength ultraviolet spectrophotometry method for the quantitative analysis.Method:Dual-wavelength ultraviolet spectrophotometry method for the determination of ethylenediamine diaceturate and vitamin c was performed,using shimadzu 2201 UV,at the dectective wavelength of 263nm for vitamin c,dectective wavelength of 192nm and the reference wavelength of 241.5nm for ethylenediamine diaceturate,sampling the reference mixture,spectrum charts of ethylenediamine diaceturate and vitamin c were recorded; RSD%of precision and recovery was calculated respectively,analyzing statistics.Result:RSD%of precision of etnylenediamine diaceturate and vitamin c was 0.61%and 0.59%respectively RSD%of recovery was 1.06%and 0.47%respectively,accepted by relative standard.Conclusion:This method is rapid,accurate and simple for determination of ethylenediamine diaceturate and vitamin c. Partâ…¡Compatibile Stability Study of Ethylenediamine Diaceturate for Injection and Vitamin C for InjectionObjective:To study the compatible stability of ethylenediamine diaceturate for injection and vitamin c for injection in 5%glucose injection.Method:Determine pH values of the sample mixture at different time points in 8h, observing external appearance,whether the mixture had gas production,turdibity and precipitation or not;and determining the content of mixture.Result:There were no significant changes in pH values and external appearance for mixture,there were no gas production,no turdibity and precipitation at room temperature within 8h.the content changes of mixture were also not significant.Conclusion:The mixture of ethylenediamine diaceturate for injection and vitamin c for injection in 5%glucose injection kept relative stability within 8h.However,the mixture was used immediately,and used them within 4h so as not to reduce the effect. |