CAJ | 학술논문

目的：探讨孟鲁司特钠片降解产物的测定方法，以有效控制药品的质量。方法采用用高效液相色谱法测定孟鲁司特钠片降解产物，AgilentZORBAXXDBC8色谱柱(4.6mm×250mm，5μm)，以磷酸盐缓冲液为流动相A，乙腈为流动相B梯度洗脱，流速1.2mL/min，检测波长为254nm，采用杂质对照品法测定降解产物。结果孟鲁司特钠浓度在1.035648~6.213888μg/mL范围内与峰面积呈良好的线性关系，主药与降解产物能达到较好的基线分离。结论该方法灵敏度高，专属性强，准确可靠，可用于药品控制。
목적：탐토맹로사특납편강해산물적측정방법，이유효공제약품적질량。방법채용용고효액상색보법측정맹로사특납편강해산물，AgilentZORBAXXDBC8색보주(4.6mm×250mm，5μm)，이린산염완충액위류동상A，을정위류동상B제도세탈，류속1.2mL/min，검측파장위254nm，채용잡질대조품법측정강해산물。결과맹로사특납농도재1.035648~6.213888μg/mL범위내여봉면적정량호적선성관계，주약여강해산물능체도교호적기선분리。결론해방법령민도고，전속성강，준학가고，가용우약품공제。
Objective To investigate a method for the determination of montelukast sodium tablets degradation products, in order to effectively control the quality of drugs. Methods HPLC for determination of montelukast sodium tablets degradation product, Agilent ZORBAX XDB C8 column (4.6 × 250mm, 5 μ m), phosphate buffer as mobile phase A, acetonitrile as mobile phase B gradient elution, flow rate 1.2ml/min, the detection wavelength was 254nm, the impurity determination of degradation products in the control sample method. Results Montelukast sodium concentration in the range of 1.035648-6.213888 μg/ml had a good linear relationship with peak area, the main drug and degradation products can achieve good baseline separation. Conclusion This method is of high sensitivity, strong specificity, accurate and reliable, and can be used for drug control.