Determination method for determining tryptophan-related substances in amino acid injection
A technology related to substances and amino acids, which is applied in the field of medicine and can solve problems that have not been reported in the literature
Active Publication Date: 2018-04-13
湖北华仁同济药业有限责任公司
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Problems solved by technology
Both EP and USP Pharmacopoeias have introductions of related substances in tryptophan raw materials, but there are no literature reports on tryptophan related substances in amino acid injections
Method used
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Embodiment 1
[0030] Take this product for direct injection; another precisely weigh an appropriate amount of tryptophan reference substance, and make a solution containing about 0.9mg per 1ml with water. Determine according to high-performance liquid chromatography, use octadecylsilane bonded silica gel as filler, as the chromatographic column of stationary phase, select acetyl tryptophan as self-control to detect tryptophan-related substances, mobile phase includes three kinds, The mobile phase A is 0.01mol / L sodium dihydrogen phosphate, and the pH is adjusted to 7.2 with sodium hydroxide solution. The mobile phase B is obtained by mixing acetonitrile, methanol and water according to the volume ratio of 45:45:10. The mobile phase C is methanol, Water is mixed according to the volume ratio of 10:90, the column temperature is 40°C, and the detection wavelength is 220nm; gradient elution is carried out according to the table below.
[0031] time (min)
Mobile phase A(%)
Mobil...
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The invention provides a determination method for determining tryptophan-related substances in an amino acid injection, and relates to the technical field of medicines. The determination method is used for determining the content of the tryptophan-related substances in amino acid injection. The method adopts high-performance liquid chromatography, adopts chromatographic column using octadecylsilane bonded silica as the stationary phase, and adopts the following three mobile phases: the mobile phase A being 0.01 mol / L sodium dihydrogen phosphate and having a pH value being adjusted with sodiumhydroxide solution and being 7.2; the mobile phase B being obtained through mixing acetonitrile, methanol and water according to a volume ratio of 45:45:10; and the mobile phase C being obtained through mixing methanol and water according to a volume ratio of 10:90 to carry out gradient elution. The relative retention time of tryptophan is analyzed and calculated to separate and determine the tryptophan-related substances in the amino acid injection. The determination method has the advantages of rapid analysis speed of the tryptophan-related substances, high accuracy and low inspection cost.
Description
technical field [0001] The invention provides a method for determining tryptophan-related substances in amino acid injections, and relates to the technical field of medicine. Background technique [0002] There are many varieties of amino acid infusion, each variety contains different types and quantities of amino acids, electrolytes, etc., and their uses are also different. It is a nutritional therapy infusion product widely used in clinical practice. Tryptophan is one of the essential amino acids, which can be transformed into 5-hydroxytryptamine, an important neurotransmitter in the human brain. It is one of the main components in amino acid injections. Because tryptophan is sensitive to light, heat, oxygen, etc. , in the preparation process of amino acid injections, if the oxygen control process, sterilization process and other links are not properly controlled, tryptophan is easy to degrade and produce related substances, and the degradation rate of tryptophan is the ra...
Claims
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Login to View More IPC IPC(8): G01N30/02G01N30/34G01N30/74
CPCG01N30/02G01N30/34G01N30/74
Inventor 尹冬丽韩瑶
Owner 湖北华仁同济药业有限责任公司