High-performance liquid chromatographic method for assay of otilonium bromide, diazepam, and related compounds in finished pharmaceutical forms.
High-performance liquid chromatographic method for assay of otilonium bromide, diazepam, and related compounds in finished pharmaceutical forms.
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用于测定成品药物剂型中奥替溴铵、地西泮和相关化合物的高效液相色谱方法。
DOI：
10.1002/jps.2600820406
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发表时间：
1993
影响因子：
3.8
通讯作者：
A. Triolo
中科院分区：
文献类型：
--
作者：
C. Mannucci;J. Bertini;A. Cocchini;A. Perico;F. Salvagnini;A. Triolo
建立了一种快速、简便、具有稳定性指标的高效液相色谱法测定复合片剂奥替溴铵、平滑肌松弛剂和地西泮含量的方法。用水溶解片剂基质，用含内标的乙腈提取药物。在5微米反相色谱柱上离心色谱，流动相为0.5 M三水合乙酸钠缓冲液，其中含有5 mM 1-七烷基磺酸一水合钠盐：甲醇（30:70,v/v，以冰醋酸调至pH 6.0）。通过从两种化合物的各种潜在降解产物中分离出两种化合物，证明了色谱系统的选择性。该方法线性、定量、重复性好。
A rapid, simple, stability-indicating assay procedure for otilonium bromide, a smooth muscle relaxant agent, and diazepam in composite tablet analysis was developed with high-performance liquid chromatography. The tablet matrix was dissolved with water, and drugs were extracted with acetonitrile containing an internal standard. An aliquot was centrifuged and chromatographed on a 5-microns, reversed-phase column with 0.5 M sodium acetate trihydrate buffer containing 5 mM 1-heptanesulfonic acid monohydrate sodium salt:methanol (30:70; v/v; adjusted to pH 6.0 with glacial acetic acid) as the mobile phase. The selectivity of the chromatographic system was demonstrated by resolving both compounds from various potential degradation products of each compound. The method is linear, quantitative, and reproducible.