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首页> 美国卫生研究院文献>Scientia Pharmaceutica >A Novel Rapid and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form
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A Novel Rapid and Validated Stability-Indicating UPLC Method for the Estimation of Drotaverine Hydrochloride and Ibuprofen Impurities in Oral Solid Dosage Form

机译：一种新的快速且经过验证的稳定性指示UPLC方法用于估算口服固体剂型中盐酸盐酸屈花石碱和布洛芬杂质

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摘要

A novel, stability-indicating, reversed-phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of pure drotaverine hydrochloride and ibuprofen in the presence of their impurities and degradation products. The method was developed using a Waters UPLC BEH C18, 100 × 2.1 mm, 1.7 µm column with a flow rate of 0.3 mL/min and detector wavelength at 210 nm. The mobile phase consisted of potassium dihydrogen orthophosphate buffer and acetonitrile. Drotaverine hydrochloride and ibuprofen were subjected to the stress conditions of oxidative, acid, base, photolytic, and thermal degradation. Degradation products resulting from the stress studies were well-resolved, thus confirming the test method as stability-indicating. Validation of the method was carried out as per International Conference on Harmonization guidelines.
机译：建立了一种新颖的，指示稳定性的反相超高效液相色谱（RP-UPLC）方法，用于在杂质和降解产物存在的情况下测定纯盐酸盐酸屈花石碱和布洛芬。该方法是使用Waters UPLC BEH C18、100×2.1 mm，1.7 µm色谱柱开发的，流速为0.3 mL / min，检测器波长为210 nm。流动相由正磷酸二氢钾缓冲液和乙腈组成。盐酸屈花石碱和布洛芬要经受氧化，酸，碱，光解和热降解的胁迫条件。应力研究产生的降解产物得到了很好的分解，从而证实了该测试方法是稳定性的指标。该方法的验证是根据国际协调大会指南进行的。

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