Determination method of phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen in compound cold medicine tablets
A technology of phenylephrine hydrochloride and chlorpheniramine acid is applied in the field of medical testing to achieve the effects of controlling product quality, comprehensive quality testing indicators and good repeatability
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Embodiment 1
[0031] [Example 1] Preparation of reference solution
[0032] Take phenylephrine hydrochloride, chlorpheniramine maleate and ibuprofen reference substances respectively, accurately weigh them, and add a solvent to make each 1ml solution containing phenylephrine hydrochloride, chlorpheniramine maleate and Ibuprofen is a mixed solution of 6.64, 0.332, and 0.132 mg, respectively, to obtain.
Embodiment 2
[0033] [Example 2] Screening of chromatographic conditions and system applicability
[0034] 2.1 Selection of mobile phase
[0035] According to the relevant literature and the specific conditions of the experiment, acetonitrile-phosphate buffer (0.04mol / L disodium hydrogen phosphate, adjusted to pH 6.0 with phosphoric acid), acetonitrile-phosphate buffer (0.04mol / L hydrogen phosphate dibasic Sodium, adjust the pH to 2.6 with phosphoric acid, acetonitrile-sodium octane sulfonate solution (3.25g / L sodium octane sulfonate solution, adjust the pH to 6.0 with phosphoric acid), acetonitrile-octane sulfonate sodium solution (3.25 g / L sodium octane sulfonate solution, adjust the pH to 2.6 with phosphoric acid), the separation effect under each mobile phase condition is as follows (see Table 1)
[0036] Table 1. Mobile phase selection results
[0037]
[0038] 2.2 Selection of Column
[0039] Try different brands and models of chromatographic columns, and finally decide to use Kromasil (C1825...
Embodiment 3
[0057] [Example 3] Preparation of test solution
[0058] Take the test compound cold tablets (batch number 20130416), accurately weigh it, and prepare a solution with a concentration of 4 mg / ml. The specific steps are to take the compound cold tablet, grind it finely, take about 20mg of the powder, accurately weigh it, place it in a 5ml volumetric flask, sonicate for 10 minutes, let it cool, add solvent to dilute to the mark, shake well, filter, and take the subsequent filtrate. Immediately.
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