A kind of assay method of tetracaine hydrochloride related substances
A technique for tetracaine hydrochloride and its determination method, which is applied in the field of determination of tetracaine hydrochloride raw materials and related substances in preparations, and can solve problems such as tumors and DNA destructiveness
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Embodiment 1
[0036] Example 1 related verification
[0037] Limit of detection, limit of quantitation:
[0038] Preparation of tetracaine hydrochloride detection limit solution: Accurately weigh 27.02mg of tetracaine hydrochloride standard substance, put it in a 50ml measuring bottle, add 20% acetonitrile solution to dissolve and dilute to the scale, accurately measure 0.4ml, put it in 50ml volume In the bottle, add 20% acetonitrile solution to dilute to the mark, accurately measure 0.5ml, put it in a 10ml measuring bottle, add 20% acetonitrile solution to dilute to the mark, accurately measure 3ml, put it in a 10ml measuring bottle, add 20% After the acetonitrile solution was diluted to the mark, the signal-to-noise ratio was 3.4.
[0039] The preparation of p-aminobenzoic acid quantitative limit and detection limit solution: accurately weigh 25.70 mg (purity 99.8%) of p-aminobenzoic acid standard substance, put it in a 100ml measuring bottle, add 20% acetonitrile solution to dissolve an...
Embodiment 2
[0068] Embodiment 2 Forced destruction test
[0069] Prepare need testing solution by following method, then carry out HPLC detection by the method of the present invention and International Pharmacopoeia (USP, EP, BP) method respectively, the results see Figure 1-Figure 8 . The results showed that 2 impurities could be detected in the test solution which was not destroyed by the international pharmacopoeia method; 5 impurities could be detected by oxygen destruction, and the main peak was not completely separated from the adjacent peaks.
[0070] 1. Undamaged: Take 10mg of tetracaine hydrochloride, put it in a 10ml measuring bottle, add 20% acetonitrile to dilute to the mark.
[0071] According to the test results of the International Pharmacopoeia, see figure 1 , according to the detection result of the method of the present invention see image 3 .
[0072] 2. Acid destruction: Take 10mg of tetracaine hydrochloride, put it in a 10ml measuring bottle, add 0.5ml of 0.5mo...
Embodiment 3
[0082] Embodiment 3 method comparison
[0083]
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