A method of high -efficiency liquid color spectrum detection method of Lidiastan
A high-performance liquid chromatography and detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of small separation degree and long analysis time of rivaroxaban S isomer and R isomer, and achieve Accurate and reliable detection results, short analysis time, and easy operation
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Embodiment 1
[0049] High performance liquid chromatography detection method for rivaroxaban:
[0050] (1) Preparation of the test solution: Accurately weigh 10 mg of rivaroxaban, place it in a 50ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution;
[0051] Preparation of reference substance solution: take rivaroxaban R isomer 10mg, put it in a 50ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as a reference substance stock solution; accurately measure an appropriate amount, and quantitatively dilute it to prepare Each 1ml contains 0.2μg solution, as the reference solution;
[0052] Preparation of system suitability test solution: take rivaroxaban 10mg, put it in a 50ml measuring bottle, add mobile phase to dissolve and dilute to the mark, and shake well to obtain a rivaroxaban solution; take 0.25ml of the reference stock solution, put it in In a 25ml measuring bottle, dilute ...
Embodiment 2
[0071] Except that the mobile phase was changed to acetonitrile-water (40%:60%, volume ratio) in the detection conditions, other steps and conditions were the same as in Example 1.
[0072] According to the above detection conditions, take 20 μl of the system suitability test solution and inject it into the liquid chromatograph, record the chromatogram, see figure 2 And table 2; Get reference substance solution 20 μ l and inject liquid chromatograph, adjust detection sensitivity, make the main component chromatographic peak height be about 10% of full scale; Accurately measure each 20 μ l of need testing solution and reference substance solution, inject respectively Liquid chromatograph, record chromatogram, calculate the content of rivaroxaban R isomer in the test sample with peak area by external standard method is 0.02%.
[0073] Table 2, the separation effect of rivaroxaban enantiomers under the conditions of Example 2
[0074]
[0075] The results show that the detec...
Embodiment 3
[0077] Except that the mobile phase was changed to acetonitrile-water (60%:40%, volume ratio) in the detection conditions, other steps and conditions were the same as in Example 1.
[0078] According to the above detection conditions, take 20 μl of the system suitability test solution and inject it into the liquid chromatograph, record the chromatogram, see image 3 And table 3; Get 20 μ l of reference substance solution and inject liquid chromatograph, adjust detection sensitivity, make the main component chromatographic peak height be about 10% of full scale; Accurately measure each 20 μ l of need testing solution and reference substance solution, inject respectively Liquid chromatograph, record chromatogram, calculate the content of rivaroxaban R isomer in the test sample with peak area by external standard method is 0.02%.
[0079] Table 3, the separation effect of rivaroxaban enantiomers under the conditions of Example 3
[0080]
[0081] The results show that the dete...
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