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首页> 外文期刊>American Journal of Analytical Chemistry >Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Darifenacin Hydrobromide in Bulk Drugs
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Development and Validation of a Stability-Indicating RP-HPLC Method for Determination of Darifenacin Hydrobromide in Bulk Drugs

机译：测定大宗药物中氢溴酸达那那新的稳定性指示RP-HPLC方法的建立和验证

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摘要

An isocratic stability-indicating reversed phase high performance liquid chromatographic method (RP-HPLC) was developed for determination of process related impurities and assay of darifenacin hydrobromide (DRF) in bulk drugs. DRF was subjected to various stress conditions such as hydrolysis (acid, base, and neutral), oxidation, photolysis and thermal degradation as per International Conference on Harmonization (ICH Q1A(R2) and Q1B) prescribed conditions to investigate the stability-indicating ability of the method. Significant degradation was observed during acidic hydrolysis and oxidative stress conditions. The chromatographic separation was accomplished on a Prodigy C8 column (250 × 4.6 mm, 5 μm) with mobile phase consisting of 0.05 M ammonium acetate (pH adjusted to 7.2 by using ammonia solution) and methanol (36% acetonitrile) in 35:65 v/v ratio in an isocratic elution mode at a flow rate of 1.0 mL/min at 25°C. Detection of analytes was carried out using photo diode array detector at a wavelength of 215 nm. The developed LC method was validated with respect to accuracy, linearity, precision, limits of detection and quantitation and robustness as per ICH guidelines.
机译：建立了等度稳定度指示反相高效液相色谱法（RP-HPLC），用于测定与工艺有关的杂质，并测定散装药物中的氢溴酸达利福星（DRF）。根据国际协调会议（ICH Q1A（R2）和Q1B）规定的条件，DRF经受了各种应力条件的影响，例如水解（酸，碱和中性），氧化，光解和热降解，以研究DRF的稳定性指示能力方法。在酸性水解和氧化应激条件下观察到显着降解。色谱分离是在Prodigy C8色谱柱（250×4.6 mm，5μm）上完成的，流动相由0.05 M乙酸铵（使用氨溶液将pH调节至7.2）和甲醇（36％乙腈）在35:65中组成在25°C下以1.0 mL / min的流速在等度洗脱模式下的v / v比。使用光电二极管阵列检测器在215 nm的波长下进行分析物的检测。根据ICH指南，已开发的LC方法在准确性，线性，精密度，检测和定量限以及耐用性方面得到了验证。

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