A method for separation and determination of preservatives, fungicides and antioxidants in pharmaceutical preparations
A technology for antiseptic bactericides and pharmaceutical preparations, which is applied in the field of pharmaceutical production industry and can solve the problems of measurement and inability to separate.
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Embodiment 1
[0135] Separation and determination of methyl p-hydroxybenzoate, m-cresol and propyl p-hydroxybenzoate in gel by liquid chromatography. Proceed as follows:
[0136] 1. Blank solution: diluent (methanol: water = 50: 50);
[0137] 2. Preparation of reference solution:
[0138] Weigh 158.4 mg of methyl p-hydroxybenzoate, 89.01 mg of m-cresol, and 17.9 mg of propyl p-hydroxybenzoate into 50ml volumetric flasks, respectively add diluents to dissolve and dilute to the mark, and shake well. Then pipette 1ml from the three volumetric flasks and place in another 50ml volumetric flask, dilute to the mark with diluent, shake well, and use it as the reference substance solution.
[0139] 3. Preparation of the test solution:
[0140] Weigh 2.0359g of the test product (becaplermin gel) and place it in a 50ml volumetric flask, add 30ml of diluent and shake to disperse the gel, ultrasonicate for 10 minutes, let cool to room temperature, and then dilute to the mark with diluent , Shake wel...
Embodiment 2
[0173] Separation and determination of methyl p-hydroxybenzoate, m-cresol and propyl p-hydroxybenzoate in ointment by liquid chromatography. Proceed as follows:
[0174] 1. Blank solution: diluent (methanol: water = 50: 50);
[0175] 2. Preparation of reference solution:
[0176] Weigh 158.4 mg of methyl p-hydroxybenzoate, 89.01 mg of m-cresol, and 17.9 mg of propyl p-hydroxybenzoate into 50ml volumetric flasks, respectively add diluents to dissolve and dilute to the mark, and shake well. Then pipette 1ml from the three volumetric flasks and place in another 50ml volumetric flask, dilute to the mark with diluent, shake well, and use it as the reference substance solution.
[0177] 3. Preparation of the test solution:
[0178] Weigh 2.0428g of the test product (cyclosporin A ointment) and place it in a 50ml volumetric flask, add 30ml of diluent and shake to disperse the ointment, ultrasonicate for 10 minutes, let cool to room temperature, then dilute to the mark with diluent...
Embodiment 3
[0210] Embodiment 3 linear curve test
[0211] 1. Preparation of linearity test solution:
[0212] Weigh 160mg of methyl p-hydroxybenzoate, 90mg of m-cresol, and 18mg of propyl p-hydroxybenzoate respectively in 50ml volumetric flasks, add diluent to dissolve and dilute to the mark, shake well, and then transfer from the three volumetric flasks Take 0.5ml, 0.8ml, 1ml, 1.2ml or 1.5ml into another 50ml volumetric flask, dilute to the mark with a diluent, shake well, and use it as a linear solution of 5 different concentrations of the reference substance.
[0213] Accurately measure 25 μL of the above-mentioned linear solutions of 5 different concentrations of reference substances prepared above, inject them into a liquid chromatograph, and adopt the mobile phase and chromatographic conditions in Example 1, and record the chromatograms.
[0214] Calculate the measured peak area, and the results are shown in Table 5. And carry out linear analysis according to the peak area and ac...
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