A method for detecting the content of sorbitol and methionine in ginkgo biloba extract preparation
A detection method and technology for methionine, which can be used in measurement devices, instruments, scientific instruments, etc., can solve the problems of high detection costs, high requirements for detection instruments, and long cycle times.
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Embodiment 1
[0039] Materials and Methods:
[0040] Instruments: Agilent1100 high performance liquid chromatography, Dikma SEDEX85 evaporative light detector, Milli-QAdvantange A10 purified water machine;
[0041] Reagents: chromatographically pure methanol, purified water, sorbitol (National Institute for the Control of Pharmaceutical and Biological Products), methionine (National Institute for the Control of Pharmaceutical and Biological Products);
[0042] Sample: Shuxuening Injection (produced by Shineway Pharmaceutical Group Co., Ltd.);
[0043] Preparation of solution
[0044] Preparation of reference solution: Take methionine and sorbitol respectively, accurately weigh them, add water to make a mixed solution containing 50 μg methionine and 1 mg sorbitol per 1 ml of solution, and obtain the solution.
[0045] The preparation of need testing solution: get 12 batches of each 1ml of Shuxuening Injection, put in 100ml volumetric flask, add water to constant volume, shake up, to get fi...
Embodiment 2
[0059] Methodology validation and results:
[0060] Linear relationship investigation: Dilute the reference substance solution and water to 2 times, 2.5 times, 5 times, 10 times, 20 times and 40 times the volume, respectively, accurately draw 20 μL of the above solution into the liquid chromatograph, and record the peak area.
[0061] Taking the common logarithm of the sorbitol injection amount (μg) as the abscissa (X), and the common logarithm of the peak area as the ordinate (Y), draw the standard curve, and the regression equation of the sorbitol is: Y=1.4397X+4.9372 , R 2 = 0.9981 (n = 6). The results show that sorbitol has a good linear relationship in the range of 0.670-13.390mg, the results are shown in table 3, and the standard curve obtained by drawing is as follows figure 1 shown.
[0062] Table 3 Sorbitol linear relationship investigation
[0063] Concentration (mg / mL) Injection volume (ug) Peak area 0.033 0.670 71.2 0.067 1.339 221.30 ...
Embodiment 3
[0095] A kind of detection method of sorbitol and methionine content in Shuxuening injection, described detection method is HPLC-UV-ELSD method, detection condition is:
[0096] Chromatographic column: octadecylsilane bonded silica gel column; mobile phase: water-methanol solution with a volume ratio of 95:5; flow rate: 0.7ml / min; column temperature: 35°C; elution method: isocratic elution for 10min ; Detection wavelength: 205nm; Drift tube temperature: 45°C; Gas flow rate: 1.5L / min.
[0097] In the reference substance solution, the concentration of methionine is 50 μg / ml, and the concentration of sorbitol is 1 mg / ml; the test solution is Shuxuening injection (batch number 17080211) diluted 100 times; the precise measurement of the reference substance solution , each 20 μ L of the test solution, injected into the liquid chromatograph respectively, according to the above-mentioned high-performance liquid chromatography conditions, the sample injection was determined, and the ch...
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