氢溴酸美沙芬含量及其杂质测定的研究

 目的:建立新的高效液相色谱测定氢溴酸美沙芬及其杂质含量的方法。方法:色谱条件以YWG C₁₈H₃₇为色谱柱;乙睛-0.1 mol·L^-1磷酸二氢钾(55:45)用磷酸调pH至4(含量)和2.5(杂质)为流动相；检测波长为280 nm；并以对乙酰氨基酚为内标测定含量。结果:含量线性范围为80～120μg·ml，回归方程Y=-0.059 6+0.131 9 X,r=0.9999(n=5),RSD=0.82%。 N,N-二甲基苯胺测定最低浓度为0.1μg·ml^-1。结论:含量测定方法简便、快速，结果准确。杂质测定灵教度高，优于药典方法。

The assay of dextromethorphan hydrobromide and its impurities

OBJECTIVE: To develop a HPLC new method for a assay of dextromethorphan hydrobromide and its impurities. METHODS: Chromatographed condition: column: YWG C₁₈H₃₇;mobile phase: acetontitrile-0. 1 mol·L^-1 potassium dihydrogeu ( KH₂PO₄ ) solution ( 55:45 ) adjusted pH with phosphoric acid to 4.0( assay) and 2.5 ( impurity). Detected wavelengths: 280 nm; Internal standard: Paracetamol. RESULT: The linear range of the assay was 80～120μg· ml^-1, and regression equation was Y=-0.059 6+0.131 9 X, r=0. 999 9(n=5), RSD=0. 82%。The measurable lowest limit of N, N-demethylaniline was 0.1μg·ml^-1.CONCLUSION:The analytical method was simple, quick and precise. The measure ment of impurities was sensitive, and better than pharmampeia methods.