Method for measuring content of chlorpheniramine maleate in chlorpheniramine maleate cream by high-performance liquid chromatography
A technology of chlorpheniramine cream and high performance liquid chromatography, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of low recovery rate and long detection time, and achieve strong specificity and good specificity , Operation and analysis steps are simple and fast
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Embodiment 1
[0028] Example 1 Determination method of chlorpheniramine maleate content
[0029] (1) Chromatographic conditions
[0030] Chromatographic column: Octyl silane bonded silica gel as packing, Angilent C18 4.6×250mm, 5μm;
[0031] The detector is an ultraviolet detector, the detection wavelength is 262nm; the flow rate is 1.0ml / min; the elution method is single-channel isocratic elution;
[0032] Column temperature 40℃;
[0033] Mobile phase: Mix acetonitrile, water and triethylamine in the following volume ratios: Acetonitrile: water: triethylamine = 130~349: 650~850:1~20, adjust the pH to 3.0 with phosphoric acid;
[0034] (2) Preparation of solution A (diluent solvent): mix acetonitrile, water and triethylamine in the following volume ratio: acetonitrile: water: triethylamine=38~42:46~56:6~12, adjust with phosphoric acid pH to 3.0;
[0035] (3) Take an appropriate amount of chlorpheniramine maleate cream, approximately equivalent to 25mg of chlorpheniramine maleate, accurately weigh it, ...
Embodiment 2
[0044] Example 2 Specificity test
[0045] Take a sample of chlorpheniramine maleate cream and a negative sample of chlorpheniramine maleate deficiency according to the above configuration method, each about 0.8406g, put them in a 50ml volumetric flask, and prepare them separately according to the method under the content determination item. For the test solution and the negative sample solution, 10μl each of the chlorpheniramine maleate reference solution, the test solution and the negative sample solution were accurately drawn, and injected into the liquid chromatograph for determination and analysis. It can be seen from the measurement results that the retention time of the chlorpheniramine peak in the test solution and the reference solution is the same, while in the chromatogram of the negative sample solution, there is no obvious chromatographic peak at the position corresponding to the chlorpheniramine peak in the reference solution. , Indicating that the negative sample d...
Embodiment 3
[0046] Example 3 Linear relationship investigation test
[0047] Precisely weigh 28.21mg of chlorpheniramine maleate reference substance (purity 99.7%), put it in a 25ml measuring flask, add mobile phase to dissolve and dilute to the mark, shake well to obtain chlorpheniramine maleate reference substance Stock solution (concentration of 1.1250mg / ml). Precisely measure the stock solution 1.0ml, 2.0ml, 4.0ml, 7.0ml, 9.0ml, put them in a 10ml measuring flask, add the mobile phase to dilute to the mark, shake well, and get it. Precisely measure each 10μl of the above solution, and inject it into the liquid chromatograph for measurement and analysis. Take the injection concentration of chlorpheniramine maleate reference substance x (mg / ml) as the abscissa, and the peak area y of chlorpheniramine as the ordinate to perform linear regression. The measurement results are shown in Table 2.
[0048] Table 2 Test results of linear relationship determination of chlorpheniramine maleate conte...
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