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Method for determining content of menbutone injection for veterinary use
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A method of determination, the technology of menbutone, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of no imported patent information, feed poisoning, etc., and achieve the effect of ensuring the safety and effectiveness of drugs
Active Publication Date: 2014-09-10
SOUTHWEST UNIV
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At present, in Europe and other regions, menbutone has been used in horses, cattle, sheep, goats, pigs and dogs for indigestion, loss of appetite, anorexia, postpartum fasting, moldy feed poisoning, colic, constipation, ketosis, Toxemia (including pregnancy toxemia), digestive dysfunction caused by liver and pancreatic diseases, etc., but there are few reports in our country, and there is no import or related patent information
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Embodiment 1
[0024] Example 1, the establishment and methodological verification of the content determination method of monbuterone injection for veterinary use
[0025] 1. Main medicines and instruments
[0026] Veterinary menbutone injection is a small test product of Chongqing Veterinary Drug Engineering Technology Research Center, batch number 20120506, content 100.16%. The reference substance of menbuxone was provided by Dr. Ehrenstorfer Company of Germany, batch number 01117.
[0087] Adopt the method for assaying the content of menbutrin injection for animals of the present invention, to the pilot test samples of menbutrin injection for animals (batch numbers are 20120701, 20120702, 20120703, 20120704, The specifications are 10mL: 1g and 100mL: 10g) for content determination. The specific chromatographic conditions are as follows: the chromatographic column is a C18 column (250mm×4.6mm); the mobile phase is 5g / L phosphoric acid solution-acetonitrile (volume ratio 1:2); the column temperature is 30°C; the flow rate is 1.0ml / min; the detection wavelength 235nm.
[0088] The results are shown in Table 9. The content determination results of four batches of veterinary monbutrinone injection products with two filling specifications all meet the regulations (the content of menbutronone should be 95.0%-105.0% of the labeled amount), and it also proves that The met...
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Abstract
The invention discloses a method for determining content of menbutone injection for veterinary use. The method adopts high performance liquid chromatography for determination, uses octadecylsilane chemically bonded silica as a filler, and mixed liquid of a 5g / L phosphoric acid solution and acetonitrile in the volume ratio of (0.9-1.1):2 as a moving phase, wherein the detection wavelength is 235-240 nm; the number of theoretical plates is not less than 2000 in terms of a menbutone peak, and the separation degree of the menbutone peak and adjacent impurity peaks is more than 1.5. The method includes the steps of precisely measuring the menbutone injection for veterinary use, namely, diluting with the moving phase in 2500 times, shaking uniformly, precisely measuring 20 micro L of the diluted solution, injecting into a liquid chromatograph, and recording the chromatogram; precisely weighing a menbutone control group, namely dissolving with the moving phase, quantitatively diluting into a solution containing 40+ / -4 micro g in 1 mL, and determining with the same method; and calculating in terms of peak area with an external standard method. The method is accurate, sensitive, simple and quick, is beneficial to control on inherent quality of the menbutone injection for veterinary use and ensures the drug safety and effectiveness.
Description
technical field [0001] The invention belongs to the technical field of drug analysis, and relates to a method for determining the content of a main drug of a veterinary drug preparation. Background technique [0002] Animal husbandry is an important industry in my country's national economy and an important part of agriculture. Literature shows that in veterinary clinics, digestive system diseases of pigs, sheep, cattle and other animals account for about 30% of the total clinical incidence, while gastrointestinal dysfunction such as loss of appetite, indigestion, constipation, abdominal distension, gastrointestinal relaxation, and rumen accumulation , concomitant or secondary to almost all diseases in animals. Animal indigestion can hinder the growth and development of animals, reduce production performance or even die, often causing large economic losses and hindering the development of animal husbandry. At present, for such diseases, cholinergic drugs such as bethanecho...
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