Compatible Stability Study Of Ampicillin Sodium For Injection Etamsylate Injection In Infusion

Objective:To study the compatible stability of bumetanide injection combined dopamine hydrochloride injection,phentolamine mesilate injection in N.S.Methods:According to clinical used doses, single and mixed solutions of ampicillin sodium and and etamylate for injection were prepared in 0.9% sodium chloride solution. PH value and external appearance (colour and clarity) of solutions were determined at 0,0.5,1,1.5,2,2.5,3,and 4h.One HPLC assay was performed for determing the content of ampicillin sodium and for injection and etamylate for injection in mixed solution at the same time .Tis method uses YWG-C18 column, methol and water(30:70) was the mobile phrase at the detective wavelength of 240nm,with the flow rate of 1.0ml/min.,at room temperature.Results:1.The specimen's PH value and external appearance :The PH value of Ampicillin Sodium for injection , which come form two different factories, were 8.55±0.048 and 8.05±0.064 respectivly. The Etamsylates of two different place, are 5.39±0.043, 6.080±.096. Those have no significant changes in PH are:the four specimen that only have one drug. They are all colorless at 0h, and sample 1,3,4 remained during 4h. But the sample 2 was turned into yellowness from 1.5h to 4h.The PH value of mixed solution of Ampicillin Sodium for injecton and Etamsylate for injection was lower than one of single ampicillin sodium for injection, but higher than one of single Etamsylates for injection.. The PH value of the mixed solution was not changed from 0 to 4h. The mixed solutions were colorless at 0. but were changed within 4h. 2.The observation of content in combined Ampicillin Sodium and Etamsylate.2.1 property test:Under this chromatographic condition , the retention time of Etamsylate and Ampicillin Sodium is 2.80min, 5.19min respectivly. The two peaks were separated completely to avoid interference.2.2 Precision results:The RSD of sample 1~4 for Ampicillin sodium and Etamsylate was 0.49﹪, 5.47﹪, 1.28﹪and 1.66﹪. Respectively.2.3The chromatographic test of stability :The content of sample 1 Ampicillin Sodium and sample3,4 Etamsylates have no significant changes within 4h. But thepeak area of sample 2 Ampicillin Sodium dropped obviously at 1.5h.2.4 The change of content of Ampicillin Sodium and Etamsylate in mixed solution: The peak area of Etamsylates raised slightly with time-dependent; There is a little chang in the peak area of sample5, RSD of peak area was 3.28﹪from 0 to 4h. There is a change in the peak shape and the peak area of sample6, 7 and 8,which was accompanied with peak shape of derivatives.Conclusion:After the compatibility of ampicillin sodium for injection, etamsylate injection N.S during 4h,they could not kept an relative stability , mixed solution was not used for clinic.