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首页> 外文期刊>Journal of Pharmaceutics >Simultaneous Determination of Clidinium Bromide and Chlordiazepoxide in Combined Dosage Forms by High-Performance Liquid Chromatography
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Simultaneous Determination of Clidinium Bromide and Chlordiazepoxide in Combined Dosage Forms by High-Performance Liquid Chromatography

机译：高效液相色谱法同时测定混合剂型中的溴化锂和氯二氮卓

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摘要

A sensitive and precise RP-HPLC method has been developed for the simultaneous estimation of clidinium bromide (CDB) and chlordiazepoxide (CDZ) in pure and pharmaceutical formulations. The separation was achieved on a Nucleodur C8(250×4.6 mm i.d., 5 μm particle size) column at 25°C. CH3CN-MeOH-NH4OAc 0.1M (30 : 40 : 30, v/v/v) was used as the mobile phase at a flow rate of 1.0 mL min−1and detector wavelength at 218 nm. Almotriptan (ALT) was used as internal standard. The validation of the proposed method was carried out for linearity, accuracy, precision, LOD, LOQ, and robustness. The method showed good linearity in the ranges of 2.5–300.0 and 3.0–500.0 μg mL−1for CDB and CDZ, respectively. The percentage recovery obtained for CDB and CDZ was 100.40–103.38 and 99.98–105.59%, respectively. LOD and LOQ were 0.088 and 0.294 μg mL−1for CDB and 0.121 and 0.403 μg mL−1for CDZ, respectively. The proposed method was successfully applied to the determination of CDB and CDZ in combined dosage forms and the results tallied well with the label claim.
机译：已经开发了一种灵敏而精确的RP-HPLC方法，用于同时估算纯制剂和药物制剂中的溴化Clidinium（CDB）和chlordiazepoxide（CDZ）。在25°C下在Nucleodur C8（250×4.6毫米内径，粒径5微米）上完成分离。使用0.1M CH3CN-MeOH-NH4OAc（30：40：30，v / v / v）作为流动相，流速为1.0 mL min-1，检测器波长为218 nm。阿莫曲坦（ALT）用作内标。针对线性，准确性，精度，LOD，LOQ和鲁棒性对提出的方法进行了验证。对于CDB和CDZ，该方法在2.5–300.0和3.0–500.0μg mL-1的范围内表现出良好的线性。 CDB和CDZ的回收率分别为100.40–103.38和99.98–105.59％。 CDB的LOD和LOQ分别为0.088和0.294μgmL-1，CDZ的分别为0.121和0.403μgmL-1。该方法成功用于组合剂型中CDB和CDZ的测定，结果与标签要求相吻合。

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