Pharmaceutical composition quality detection method
A quality detection method and detection method technology, which is applied in the field of medicine, can solve the problems of simultaneous detection of puerarin and shikimic acid, etc., and achieve the effect of simple operation and good repeatability
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preparation example Construction
[0027] The preparation method of the mixed reference substance solution is as follows: take an appropriate amount of the puerarin reference substance, accurately weighed, add methanol to make a puerarin stock solution containing 90 μg per 1 ml, and take an appropriate amount of the shikimic acid reference substance, accurately weigh it, add water to make each 1ml of shikimic acid stock solution containing 120μg, and then take appropriate amount of puerarin stock solution and shikimic acid stock solution respectively, and use 50% methanol to make a mixed reference solution containing 45μg puerarin and 60μg shikimic acid per 1ml.
[0028] Preparation method of the test solution: take about 0.15 g of the content of Songling Xuemaikang, accurately weigh it, put it in a 50ml measuring bottle, add an appropriate amount of 50% ethanol-water solution, ultrasonically treat it (250w, frequency 40khz) for 30 minutes, and let it cool , Dilute with 50% ethanol-water solution and set the vol...
experiment example 1
[0030] Experimental example one mobile phase buffer solution investigation
[0031] The inventor has investigated the impact of several different buffered saline solutions on the detection results, and the results are shown in the following table 1:
[0032] Table 1 buffer solution investigation results
[0033]
[0034] According to the results in Table 1, it can be seen that the type of buffer solution has a significant impact on the detection results. When using common buffer solutions such as sodium dihydrogen phosphate, ammonium dihydrogen phosphate, and ammonium dihydrogen citrate, the detection spectrum will have unstable baselines and substandard resolution, resulting in inability to perform accurate quantification; while using ammonium acetate buffer In solution, puerarin and shikimic acid have good separation effect, no interference, stable baseline and good peak shape.
experiment example 2
[0035] Experimental example two buffer solution concentration investigation
[0036] The inventor investigated the concentration of the buffer solution, and the results are shown in Table 2:
[0037] Table 2 buffer solution concentration investigation result
[0038]
[0039]
[0040] According to the results in Table 2, the concentration of the buffer solution also has a certain influence on the experimental results. Under the 50mM concentration condition, the shikimic acid separation degree is not up to standard, and under the 100mM concentration condition, shikimic acid appears to wrap peaks, and the puerarin separation degree is not up to standard. Can not meet the needs of quantitative detection; only under the condition of 10-20mM concentration, puerarin and shikimic acid can achieve baseline separation, especially under the condition of 20mM concentration, the target peak separation is good, there is no interference, and the baseline is stable, which can meet the ...
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