Stability Indicating Nature of RP-HPLC method for Determination of Impurity profile and Degradation impurities in Duloxetine Hydrochloride

Veera Reddy. Arava; Sreenivas Ulareddy. B; at Makuru; Kameshwar Rao. Cherukuri; Madhusudhanreddy. Bethi

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Stability Indicating Nature of RP-HPLC method for Determination of Impurity profile and Degradation impurities in Duloxetine Hydrochloride

机译：RP-HPLC法测定盐酸度洛西汀中杂质和降解杂质的稳定性指示性质

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The objective of the present work was to develop stability indicating RP-HPLC method for Duloxetine Hydrochloride in the presence of its degradation products generated from forced degradation studies. Duloxetine Hydrochloride was subjected to the stress conditions and it is sensitive towards Acid and Oxidative degradation. Duloxetine Hydrochloride was found to be stable to Basic, Photolytic, Thermal and Humidity conditions attempted. Successful separation of Duloxetine Hydrochloride from degradation impurities under stress conditions was achieved on YMC Pack C8, 250 X 4.6 mm, 5μm column using a gradient mixture of solvent A (0.01 M of Sodium Di hydrogen Orthophosphate and 1.0g of 1-Heptane Sulfonic Acid Sodium Salt transfer in 1000mL of water, adjust the pH of the above solution to 3.0 + 0.1 using Orthophosphoric acid) and solvent B (Acetonitrile). The flow rate is 1.0ml/min and the detection wavelength is 217nm. Statistical analysis proved the method to repeatable, specific and accurate for estimation of Duloxetine Hydrochloride and its degradation impurities. It can be used as a stability indicating method due to its effective separation of the drug from its degradation impurities.

机译：本工作的目的是在存在由强制降解研究产生的降解产物的情况下，开发盐酸度洛西汀的稳定性指示RP-HPLC方法。盐酸度洛西汀经受了应力条件，并且对酸和氧化降解敏感。发现盐酸度洛西汀对尝试的碱性，光解，热和湿度条件稳定。在YMC Pack C8、250 X 4.6 mm，5μm色谱柱上使用溶剂A（0.01 M的正磷酸二氢钠和1.0g的1-庚烷磺酸钠）的梯度混合物在应力条件下成功地从降解杂质中分离出盐酸度洛西汀将盐转移至1000mL水中，使用正磷酸和溶剂B（乙腈）将上述溶液的pH值调节至3.0 + 0.1。流速为1.0ml / min，检测波长为217nm。统计分析证明该方法可重复，特异性，准确地估算盐酸度洛西汀及其降解杂质。由于它可以有效地从降解杂质中分离出药物，因此可以用作稳定性指示方法。

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《Der Pharma Chemica: journal for medicinal chemistry, pharmaceutical chemistry and computational chemistry》 |2012年第4期|共7页
作者
Veera Reddy. Arava; Sreenivas Ulareddy. B; at Makuru; Kameshwar Rao. Cherukuri; Madhusudhanreddy. Bethi;
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Stability Indicating Nature of RP-HPLC method for Determination of Impurity profile and Degradation impurities in Duloxetine Hydrochloride

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