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首页> 外文期刊>Journal of liquid chromatography and related technologies >Development and validation of a stability indicating RP-LC method for the estimation of process related impurities and degradation products of duloxetine hydrochloride and phthalic acid in duloxetine hydrochloride delayed release capsules
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Development and validation of a stability indicating RP-LC method for the estimation of process related impurities and degradation products of duloxetine hydrochloride and phthalic acid in duloxetine hydrochloride delayed release capsules

机译：稳定性指示RP-LC方法的开发和验证，用于评估盐酸度洛西汀缓释胶囊中与工艺有关的杂质和盐酸度洛西汀和邻苯二甲酸的降解产物

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摘要

A stability-indicating gradient reverse phase liquid chromatographic method was developed for the quantitative determination of process related impurities and forced degradation products of duloxetine hydrochloride, duloxetine phthalamide impurity, and phthalic acid in duloxetine hydrochloride delayed release capsules. The method was developed by using Inertsil ODS-4 (150mm x4.6 mm) 3 μm column with mobile phase containing a gradient mixture of solvent A (0.02M ammonium dihydrogen phosphate and 0.01M 1-octane sulfonate sodium salt, pH adjusted to 2.5 with orthophosphoric acid) and B (750:300mL mixture of acetonitrile and methanol). The flow rate of the mobile phase was 1.8mL/min with column temperature of 50°C and detection wavelength at 230 nm. Duloxetine hydrochloride was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Duloxetine hydrochloride was found to degrade significantly in acid, base and oxidative stress conditions. The degradation products were well resolved from phthalic acid, duloxetine and its impurities. The mass balance was found to be in the range of 95-105% in all the stressed conditions, thus proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision and robustness.
机译：建立了一种指示稳定性的梯度反相液相色谱方法，用于定量测定盐酸度洛西汀缓释胶囊中与工艺有关的杂质和盐酸度洛西汀，度洛西汀邻苯二甲酰胺杂质和邻苯二甲酸的强迫降解产物。该方法是通过使用Inertsil ODS-4（150mm x4.6 mm）3μm色谱柱开发的，流动相中含有溶剂A（0.02M磷酸二氢铵和0.01M 1-辛烷磺酸钠盐，pH调节至2.5）的梯度混合物（含正磷酸）和乙（750：300mL乙腈和甲醇的混合物）。流动相的流速为1.8mL / min，柱温为50°C，检测波长为230 nm。使盐酸度洛西汀经受氧化，酸，碱，水解，热和光解降解的应力条件。发现盐酸度洛西汀在酸，碱和氧化应激条件下会显着降解。降解产物可以很好地从邻苯二甲酸，度洛西汀及其杂质中分离出来。发现在所有应力条件下，质量平衡均在95％至5％之间，从而证明了该方法的稳定性指示能力。根据ICH指南，针对特异性，线性，检测和定量限，准确性，精密度和鲁棒性，对开发的方法进行了验证。

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