Method for detecting related substances in 4-oxime methyl-1-naphthoic acid
A detection method and a technology related to substances, which are applied in measuring devices, instruments, scientific instruments, etc., can solve problems such as no patent literature reports, and achieve the effects of stable durability, good durability, and high sensitivity
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[0041] Example 1
[0042] S1: Preparation of the solution: Precisely weigh 4-methyl-1-naphthoic acid Top 10 mL in a 20 ml capacity bottle, and then take this solution to 50 ml of capacity bottle, dissolve and dilute to the scale of the solvent with a solvent Mix;
[0043] S2: Preparation of the test solution: Precision 4-methyl-1-naphthoate for 10 mg of 20 ml of capacity bottle, dissolved and diluted to the scale line with a solvent, mixed;
[0044] S3: High performance liquid chromatography: Kromasil 100-5-C18 column: 4.6mm × 100 mm, 5 μm; flow phase is acetonitrile: 0.01% hydrochlorous acid solution = (30 ~ 80): (70 ~ 20) (v / v) Gradient elution, gradient elution time and the volume ratio of the flow phase acetonitrile are: 0min ~ 8min, 30% ~ 70% operation; 8min ~ 12min, 70% ~ 80% operation; 12min ~ 15min, 80% operation 15.1min ~ 20min, 30% operation; flow rate: 1.2ml / min; column temperature: 30 ° C; UV detector detection wavelength: 245 nm; injection volume: 10 μL; inject th...
Example Embodiment
[0046] Example 2
[0047] Example 2 2 and Example 1 The detection method is the same, and the difference is that the chromatographic conditions of S2 are specifically:
[0048] The flow phase is acetonitrile: 0.1% hydrochlorous acid solution = (30 ~ 80): (70 ~ 20) (V / V) perform gradient elution, detection results figure 2 Indicated.
[0049] Depend on figure 2 It can be seen that each component can effectively separate, and the impurity A content of 4-methyl-1-naphthoic acid is calculated by the main component itself, and the impurity B content is 0.0019%, and the impurity C content is 0.0611%. The impurity D content was 1.1368%, the impurity E content was 0.0486%, and the peak type was good.
Example Embodiment
[0050] Example 3: Exclusive Test
[0051] S1: Treatment of impurity reserves: Take impurities A, impurity B, impurities C, impurities D, impurity E, and adding a solvent to a concentration of 0.10 mg / ml, as a stock solution.
[0052] S2: Impurity limit solution Preparation: Mission of impurity stock solution 0.5ml in a 20 ml volumetric flask, resulting in an impurity limit solution having a concentration of 2.50 μg / mL;
[0053] S3: System Applicability Solution Preparation: Precision 4-methyl-1-naphthoic acid Tablet 10 ml of capacity bottle, and add 0.5 ml of the impurity stock solution, dissolved and diluted with a solvent, mixed uniform. The concentration of 4-methyl-1-naphthoic acid was 500 μg / ml, and the concentration of each impurity was 2.50 μg / mL;
[0054] S4: Determination of high performance liquid chromatography in Example 1 was measured, and the liquid chromatograph and system applicable solutions were injected into the liquid chromatograph, wherein the system a...
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