Compatible Stability Study Of Bumetanide For Injection Combine With Dopamine Hydrochloride, Phentolamine Mesilate Injection

Objective:To study the compatible stability of bumetanide injection combined dopamine hydrochloride injection,phentolamine mesilate injection in N.S.Method:1.Sample preparation:1.1An amount of injections content equivalent to 100mg bumetanide ,5mg dopamine hydrochloride and 10mg phentolamine mesilate were accurately aborbsd respectively.Put them into 100 ml N.S. and mixed .1.2An amount of injections content equivalent to 100mg bumetanide , 5mg dopamine hydrochloride and 10mg phentolamine mesilate were accurately aborbsd respectively.Put each of them into 100 ml N.S.apart and mixed .2.The value of pH measurement.Determine pH values of the samples in"1.1"at 0,0.5,1,1.5,2,3,4,5,6h, observing the external appearance(colour,clarity) at the same time.3 Determine the content of Dopamine hydrochloride in mixed injection3.1property testChromatographic assay was performed on a YWG-C18 column using the mobile phase of phosphate buffered saline(pH5.8)-methol(98:2),at the detective wavelength of 280nm,with the flow rate of 1.0ml/min. 4 samples in"1"were injected apart.The chromatograms are shown.3.2 Chromatographic test of intra-day precision A same concentration of Dopamine/N.S. solution was taken tocontinuously analyze for five times, then RSD of peak area of Dopamine was caculated.3.3 measurement of the content of Dopamine hydrochloride in mixed injectionThe sample in"1.1"was analyzed at 0,0.5,1,1.5,2,3,4,5,6h.The peaks area of Dopamine were determined.4. Determine the content of bumetanide injection and phentolamine mesilate injection in mixed injection4.1 property testAnother mobile phase was methol:water(60:40)(pH2.5) at the detective wavelength of 220nm,with the flow rate of 1.0ml/min. 4 samples in"1"were injected apart and the chromatograms were recored.4.2 Chromatographic test of intra-day precision A same concentration of Bumetanide /N.S. solution and phentolamine /N.S. solution were taken apart to continuously analyze for five times, then RSD of peak area of bumetanide and phentolamine were caculated respectively.4.3 measurement of the content of bumetanide and phentolamine in mixed injectionThe sample in"1.1"was analyzed at 0,0.5,1,1.5,2,3,4,5,6h.The peaks area of Bumetanide and Phentolamine were determined.Result:1. The value of pH measurement.At room temperature in 6h ,there were no significant changes in pH value and external appearance for mixed solution.2. The content of Dopamine in mixed injection determination2.1 property testThe retention time of Dopamine was 4.35min under this chromatographic condition.2.2 Chromatographic test of intra-day precision RSD was 2.28%,accepted by reletive standard.2.3 The content of Dopamine in mixed injection No significant changes in the content of Dopamine in 6h for mixed solution.3.The content of Bumetanide and Phentolamine in mixed injection determination3.1 property testUnder this chromatographic condition,the retention time of Bumetanide and Phentolamine was 4.21min and 9.17min.Two peaks were separated enough for avoiding interferance.3.2 Chromatographic test of intra-day precision RSD was 1.74% and 0.68%,accepted by reletive standard.3.3 The content of Dopamine in mixed injection No significant changes in the content of Bumetanide and Phentolamine in 6h for mixed solution.Conclusion: After the compatibility of bumetanide injection, dopamine hydrochloride injection,phentolamine mesilate injection in N.S,in 6h,they kept relative stability.