Analysis Of Arecoline In Administration Of Pediatric Digestion Tablets Suspension Under GLP Condition

Objective:To find out a method for analyzing analysis of Arecoline in administration of pediatric digestion tablets suspension under GLP condition,based on the analysis of the original manufacturers.Methods: When water was used for medicine,using the original chromatographic methods : A Thermo Bio Basic SCX column(4.6×250mm,5μm)was used for the separation,with 0.1% phosphoric acid solution(Adjuded p H value to 3.8 by Ammonia water)-Acetonitrile(35: 65)as the mobile phase,and the flow rate was 1.0 m L/min.The determination wavelength was 215 nm,the column temperature was 30 ℃ and the injection volume was 10 μL.The sample preparation method is provided based on the original method,and the treatment method for the high and low concentration suspension is obtained.For the high concentration,the sample was obtained by the method of Take – Ultrasonic-Filtration;For the low concentration,the sample was obtained by the method of Ultrasonic-Centrifugation-Taking the steamed to dry-Vortex redissolution with methanol-Centrifugation.When administration of Pediatric digestion tablets solution with 0.9% Sodium Chloride Injection as solvent,HPLC cannot detect arecoline peak,preliminarily consider to establish a new testing method by LC-MS.Results: 1.Determination of Arecoline in Administration of Pediatric digestion tablets solution-High concentration(water as solvent)The linear range of Arecoline was 5.09 to 20.35 μg/m L(r=0.9994).RSD of precision were 5.25% and 5.54%(n=6).The stability of 6h was stable in the high concentration suspension under room temperature.2.Determination of Arecoline in Administration of Pediatric digestion tablets solution-Low concentration(water as solvent) The linear range of Arecoline was 3.05 to 15.26 μg/m L(r=0.9998).RSD of precision were 5.60% and 3.63%(n=6).The stability of 3d was stable in the low concentration suspension under room temperature.3.Determination of Arecoline in Administration of Pediatric digestion tablets solution-(0.9% Sodium Chloride Injection as solvent)The linear range of Arecoline was 50.4 to 2015.2 ng/m L(r=0.9979).RSD of precision were 5.03% and 0.84%(n=6).The stability of 4h was stable in the suspension under room temperature.Conclusion: This method was accurate,and can be used for the Analysis of Arecoline in Administration of Pediatric digestion tablets solution under GLP Condition...