HPLC法测定盐酸异丙肾上腺素气雾剂雾滴分布、每揿主药含量的探讨

HPLC determination of droplet size distribution,content of active ingredient in content of an actuation isoprenaline hydrochloride aerosol

目的:建立 HPLC 法测定盐酸异丙肾上腺素气雾剂雾滴分布、每揿主药含量和含量。方法:采用 Shim Pack VP-ODS(250 mm×4 6 mm,5 μm)色谱柱;流动相为含1.76 g 庚烷磺酸钠的水溶液-甲醇(800:200),用1 mol·L^(-1)磷峻调节 pH 至3.0;检测波长:280 nm。结果:在3.5～700 μg·mL^(-1)浓度范围,盐酸异丙肾上腺素的峰而积与浓度呈良好线性关系(r=0.9999),平均加样回收率分别为99.3%,98.7%,98.2%(n=9)。结论:本法测定盐酸异丙肾上腺素气雾剂雾滴分布、每揿主药含量和含量简捷、灵敏、准确度高,不受辅料干扰。考察结果显示,国内盐酸异丙肾上腺素气雾剂的质量有待进一步提高。

Objective：To develop an HPLC method for the determination of droplet size distribution, content of active ingredient in an actuation and content of isoprenaline hydrochloride aerosol. Methods：The chromatographic conditions were：Shim Pack VP- ODS column（250 mm ×4. 6 mm,5 μm） ,the mixture that dissolved 1.76 g of sodium 1 - heptanesulfonate in 800 mL of water and 200 mL methanol （ adjust with 1 mol·L^-1 phosphoric acid to a pH of 3.0 ± 0. 1 ） as mobile phase with detection wavelength of 280 nm. The determination of droplet size distribution was analyzed by devices for aerodynamic size distribution, following the standard ChP procedure. Results：The calibration curve was linear within the range of 3.5 - 700 μg ·mL^-1 （ r = 0. 9999） for isoprenaline hydrochloride. The average recovery rate was 99. 3% ,98.7% and 98.2% respectively（ n =9）. Conclusion：The method is simple, sensitive, accurate and suitable for determination of isoprenaline hydrochloride aerosol and its content of active ingredient in an actuation and droplet size distribution. As the results, the quality of isoprenaline hydrochloride has to be improve.