Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry and Computational Chemistry

Abstract

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

Author(s): Veera Reddy. Arava, Sreenivas Ulareddy. Bandat Makuru, Kameshwar Rao. Cherukuri, Madhusudhanreddy. Bethi

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.


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