Method for detecting related substances in antibacterial eye drops
A technology related to substances and eye drops, applied in the field of medicine, can solve the problems of poor detection specificity and achieve high accuracy, good repeatability, and good specificity
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[0044] In the present invention, the preparation method of the linear relationship diagram preferably includes the following steps: preparing solutions with different concentrations of reference substances in the series of related substances, and performing high performance liquid chromatography on the solutions with different concentrations of reference substances in the series of related substances to obtain the peak area of the related substances , linearly fitting the peak area of the related substance with the concentration of the related substance, taking the peak area as the ordinate and the concentration as the abscissa, and performing linear regression to obtain a linear relationship diagram.
[0045] In the present invention, the concentrations of related substances in different concentration solutions of the related substance series reference substances are preferably quantitation limit concentration, 0.5 μg / mL, 0.8 μg / mL, 1.0 μg / mL and 1.5 μg / mL.
[0046] In the...
Embodiment 1
[0058] 1. Experimental samples
[0059] The reference substance information is shown in Table 3:
[0060] Table 3 Reference substance information
[0061]
[0062]
[0063] (1.1) Blank solvent: Add 1.36g of tetrabutylammonium hydrogensulfate, 1.0g of potassium dihydrogen phosphate and 0.02g of anhydrous sodium sulfite to 500mL of water to dissolve, add 2mL of phosphoric acid, dilute to 1000mL with water, and mix well to obtain a blank solvent ; The solvent mentioned in the embodiment is the blank solvent.
[0064] (1.2) Reference substance stock solution
[0065] Impurity A solution: Accurately weigh 10mg of the impurity A reference substance and place it in a 100mL measuring bottle, dilute to the mark with a solvent, shake well, and use it as the impurity A solution.
[0066] Impurity F solution: Accurately weigh 10 mg of the impurity F reference substance, place it in a 100 mL measuring bottle, dilute to the mark with a solvent, shake well, and use it as the impurit...
Embodiment 2
[0093] Specificity verification: the test solution, blank solvent, raw drug solution, and excipient solution were destroyed by acid, alkali, oxygen, and light, respectively, to investigate the degradation pathway of moxifloxacin hydrochloride eye drops, and to verify the specificity of the detection method of the present invention .
[0094] (1) Experimental method
[0095] (1.1) Strong acid destruction: Precisely measure 2 mL of antibacterial eye drops and place it in a 10 mL measuring bottle, add 1 mL of aqueous hydrochloric acid solution with a concentration of 1 mol / L, degrade it at 80°C for 8 hours, take it out, add 1 mL of hydrogen with a concentration of 1 mol / L Neutralize the aqueous solution of sodium oxide, let it cool to room temperature, dilute to the mark with a solvent, shake well, and obtain the test solution for strong acid degradation treatment; use the same treatment method, replace the antibacterial eye drops with a blank solvent, and obtain strong acid degr...
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