A kind of detection method of mosapride citrate related substance
A technology for mosapride citrate and related substances, which is applied in the detection field of mosapride citrate related substances, can solve the problems of inability to achieve accurate detection, incomplete detection of impurities, low separation degree of impurities, etc., and achieves a baseline The effect of large fluctuation, accurate detection and low background interference
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
Method used
Image
Examples
Embodiment 1
[0046] Example 1 Detection of related substances of mosapride citrate
[0047] Preparation of the test solution: take an appropriate amount of mosapride citrate, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing 0.25 mg per 1 ml.
[0048] High-performance liquid chromatography detection conditions: mobile phase: 0.05mol / L citric acid solution (sodium hydroxide test solution to adjust the pH value to 3.0)-methanol (60:40), flow rate: 1ml / min; detection wavelength: 275nm; column Temperature: 35°C, injection volume is 20 μl.
[0049] Prepare need testing solution according to the above-mentioned method, carry out high performance liquid chromatography detection, the result is as follows figure 1 As shown, the number of impurities detected by it is small, and the chromatographic peak response value is low, and the detection sensitivity is low.
Embodiment 2
[0050] Example 2 Detection of related substances of mosapride citrate
[0051] Preparation of the test solution: take an appropriate amount of mosapride citrate, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing 0.5 mg per 1 ml.
[0052] High-performance liquid chromatography detection conditions: mobile phase: 0.05mol / L sodium dihydrogen phosphate buffer solution (adjust the pH value to 3.0 with triethylamine)-acetonitrile (72:28), flow rate: 1ml / min; detection wavelength: 276nm; column Temperature: room temperature (28°C), the injection volume is 10 μl.
[0053] Prepare need testing solution according to the above-mentioned method, carry out high performance liquid chromatography detection, the result is as follows figure 2 As shown, the number of impurities detected by it is small, and the chromatographic peak response value is low, and the detection sensitivity is low.
Embodiment 3
[0054] Example 3 Detection of related substances of mosapride citrate
[0055] Preparation of the test solution: take an appropriate amount of mosapride citrate, accurately weigh it, dissolve it with mobile phase and quantitatively dilute it to make a solution containing 1.0 mg per 1 ml.
[0056] High-performance liquid chromatography detection conditions: 0.1M sodium dihydrogen phosphate solution (phosphoric acid to adjust pH=4.0): methanol ratio of 75:25, flow rate: 1ml / min; detection wavelength: 274nm; column temperature: 35°C, injection volume: 10μl . Prepare need testing solution according to the above-mentioned method, carry out high performance liquid chromatography detection, the result is as follows image 3 As shown, the impurity peak separation effect of the detection result is poor, the peak shape is asymmetrical, and the chromatographic peak response value is low, and the detection sensitivity is low.
PUM
| Property | Measurement | Unit |
|---|---|---|
| separation | aaaaa | aaaaa |
Abstract
Description
Claims
Application Information
Login to View More