Quality control method of throat clearing dropping pill

2008 
The invention relates to a quality control method of an HPLC finger-print of a throat clearing dropping pill. The method comprises the steps of the measurements of a high-polar finger-print taking gallic acid as a reference and a low-polar finger-print taking indigo blue as a reference, wherein the chromatographic column of the high-polar finger-print is Diamonsil C18 (4.6*250mm, 5 microns), gradient elution is adopted, a mobile phase A is acetonitrile, B is 0.1 percent phosphoric acid, the detection wavelength is 165nm, the column temperature is 25 DEG C, and the flowing speed is 1.0mL/min; the chromatographic column of the low-polar finger-print is Diamonsil C18 (4.6*250mm, 5 microns), the gradient elution is adopted, a mobile phase A is methanol, B is 0.1 percent phosphoric acid, the detection wavelength is 185nm, the column temperature is 30 DEG C, and the flowing speed is 1.0mL/min. By adopting the measuring method, the internal quality of the throat clearing dropping pill can be effectively controlled, and the method has the characteristics of high precision, stability, repetitiveness and guarantee of the stability and consistence of product quality, thereby guaranteeing the safety and effectiveness of a product.
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