CAJ | 학술논문

目的：建立HPLC法，测定小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量并考察其含量均匀度。测得小儿氨酚黄那敏颗粒中马来酸氯苯那敏的含量为0.023%，占标示量的百分含量为90.89%，根据药典规定，该样品马来酸氯苯那敏的含量符合要求(占标示量的90.0%～110.0%)[1]。色谱柱为C18柱，流动相为乙腈-水（36%醋酸溶液40ml与1ml三乙胺稀释至1000ml）,流速为lm/min，检测波长为260nm，进样量为5μl。马来酸氯苯那敏的峰面积Y对进样量X(μg)的回归曲线为：Y=534.14X+41.358；R2=0.9953，线性范围为14～140μg/ml。该方法快速简便，重复性好，适用于小儿氨酚黄那敏颗粒中的马来酸氯苯那敏的质量控制。
목적：건립HPLC법，측정소인안분황나민과립중마래산록분나민적함량병고찰기함량균균도。측득소인안분황나민과립중마래산록분나민적함량위0.023%，점표시량적백분함량위90.89%，근거약전규정，해양품마래산록분나민적함량부합요구(점표시량적90.0%～110.0%)[1]。색보주위C18주，류동상위을정-수（36%작산용액40ml여1ml삼을알희석지1000ml）,류속위lm/min，검측파장위260nm，진양량위5μl。마래산록분나민적봉면적Y대진양량X(μg)적회귀곡선위：Y=534.14X+41.358；R2=0.9953，선성범위위14～140μg/ml。해방법쾌속간편，중복성호，괄용우소인안분황나민과립중적마래산록분나민적질량공제。
Objective:To establish a HPLC method for the content assaying and uniformity determination of chlorphenamine maleate in Xiao’er Anfenhuangnamin Granules and chlorphenamine maleate granules. Measured Chlorpheniramine Maleate content of 0.023%, Xiao’er Anfenhuangnamin Granules in representing the labeled amount of percentage of 90.89%, according to Pharmacopoeia, the sam-ple Chlorpheniramine maleate content found Requirements (accounting for 90.0%of the labeled amount of 110.0%).The C18 column (250mm ×4.6mm,5m)was used and the mobile phase was acetonitrile water (40ml 36%acetic acid and 1ml triethylamine diluted to 1000ml),with pH adjusted with phosphoric acid to2.5,the flow rate of 1ml per min and the wavelength of detection of 260nm,and injection amount of 20μl.Chlorphenamine maleate showed a good linear relationship in the range of 14~140μg/ml,Y=534.14X+41.358,r=0. 9953.The method is simple and accurate,and can be used to determine the content assaying of chlorphenamine maleate in Xiao’er Anfenhuangnamin Granules and chlorphenamine maleate granules.