Method for assaying cedinafei and derivative thereof
A technology for sildenafil and derivatives, applied in the field of detection of sildenafil citrate and its derivatives, can solve the problems of lack of testing equipment, difficulty in screening, etc., achieve a wide control range, simple preparation, and eliminate false negatives the effect of the result
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Embodiment 1
[0021] Embodiment 1, detection method
[0022] The inventive method concrete operation is as follows:
[0023] 1. Sampling volume
[0024] For different types of samples to be tested, the recommended sampling volume is shown in Table 1 below.
[0025] Table 1 Recommended sampling scale
[0026] dosage form
Sampling volume
tablet
1
Contents of 1 capsule
honey pill
1 / 4
single dose oral solution
1 / 2 stick
other solid
0.1~0.2g
[0027] 2. Preparation of the test article
[0028] Preparation of solid test sample Add 6-12ml of methanol to the finely ground or chopped sample, grind to dissolve, filter or centrifuge, divide the filtrate or supernatant into three parts, and put them in three test tubes respectively;
[0029] Preparation of liquid test product Measure the samples directly and place them in three test tubes respectively;
[0030] 3. Color reaction
Embodiment 2
[0041] Embodiment 2, the accuracy test that the inventive method detects sildenafil
[0042] 40 batches of samples are detected by the method of the present invention, and at the same time according to the State Drug Administration Drug Inspection Supplementary Inspection Method and Inspection Item Approval Document (2006009, issued on March 14, 2006), the HPLC-MS-MS method is used to check other methods. Lafei, sildenafil, vardenafil, hongdenafil and Huanyang base, the results are shown in Table 3.
[0043] Table 3: Test results of multiple batches of samples
[0044] product name
Sampling volume
Color rendering result
mass spectrometry results
sample 1
Contents of 1 capsule
①Orange precipitate
②No precipitation
③No precipitation
sample 2
1 pill
①No precipitation
②No precipitation
③No precipitation
Does not contain * ...
Embodiment 3
[0049] Embodiment 3, the detection of sildenafil derivative
[0050] The method of the present invention can not only detect sildenafil, but also detect sildenafil derivatives, see formula II, formula III, formula IV, formula V and formula VI. The detection method and positive result judgment are the same as the detection of sildenafil.
[0051]
[0052]
[0053] Get vardenafil hydrochloride reference substance (formula V), reddenafil (formula IV) and reddenafil (formula VI) raw materials, adopt the method of the present invention to detect, all show positive reaction.
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