Method for detecting sodium-to-potassium ion ratio in potassium sodium dehydroandrographolide succinate bulk drug
A detection method and a technology of raw materials, applied in the direction of material separation, measuring devices, and analytical materials, etc., can solve problems such as inability to accurately evaluate the quality of raw materials, difficulty in industrial application and promotion, and low penetration rate of instruments and equipment. Effects of matrix interference, high accuracy, and low cost
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Embodiment 1
[0034] Embodiment 1: the selection of chromatographic conditions
[0035] In this test, the chromatographic method of this test is screened by adjusting the composition and ratio of the mobile phase, pH value, flow rate, column temperature, etc.
[0036] Chromatographic condition screening scheme
[0037]
[0038] Take an appropriate amount of this product, weigh it accurately, add water to dissolve and dilute to make a solution containing 400 μg per 1 ml, as the test solution. Inject into the liquid chromatograph and record the chromatogram. The screening results of chromatographic conditions are shown in the table below.
[0039]
[0040] The results in the table above show that scheme 3 is the best chromatographic condition.
Embodiment 2
[0041] Embodiment 2: the making of standard curve
[0042] Chromatographic conditions: adopt the chromatographic conditions of Scheme 3 of Example 1.
[0043] Take an appropriate amount of sodium chloride reference substance and potassium chloride reference substance dried at 120°C to constant weight, accurately weighed, dissolve in water and quantitatively dilute to make a solution containing 400 μg of sodium chloride per 1 ml (equivalent to 1 ml of ml containing 157.4 μg of sodium ions) and 480 μg of potassium chloride per 1 ml (equivalent to 251.8 μg of potassium ions per 1 ml), as a standard stock solution. Precisely measure 1 ml, 1 ml, and 3 ml of the standard stock solution, put them in 20 ml, 10 ml, and 20 ml respectively, dilute to the mark with water, shake well, and use it as a series of mixed standard solutions of sodium and potassium ions. Precisely measure 20 μl each of the series of sodium and potassium ion mixed standard solutions, and inject them into the liqu...
Embodiment 3
[0045] Embodiment 3: method accuracy
[0046]Weigh 40.15 mg of sodium chloride and 48.49 mg of potassium chloride dried at 120 ℃ to constant weight, weigh them accurately, put them in a 100 mL measuring bottle, add water to dissolve and dilute to the mark, and shake well to obtain the mixed stock solution. Select 3 concentration levels of 50%, 100% and 150% of the limit concentration, weigh three parts of Yanhuning respectively about 20 mg for each concentration level, add 2.5 mL of sodium ion and potassium ion mixed standard stock solution, 5.0 mL and 7.5 mL, dilute to 50 mL volumetric flask, shake well. Precisely measure 20 μl of each of the above solutions and inject them into the liquid chromatograph respectively. The recovery of the method was calculated according to the external standard curve method. The results are shown in the table below.
[0047] The results of the standard recovery test
[0048]
[0049] The results showed that the average recovery rate of s...
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