A Simple, Novel Validated Stability Indicating RP-HPLC method for estimation of Duloxetine HCl in Capsule Pharmaceutical Formulation

Abstract:

The object of current work was to study the degradation behavior of duloxetine under different ICH recommended stress condition under reverse phase high performance liquid chromatographic (HPLC) method and to establish a novel, validated stability-indicating reverse phase high performance liquid chromatographic method for the determination of duloxetine in presence of its impurities and forced degradation products in pharmaceutical formulation. The chromatographic separation was achieved on Hypersil, BDS- C8 , (250 mm × 4.6 mm, 5 μM) column with a mobile phase containing a mixture of Acetonitrile : Phosphate buffer pH 3.0 (50:50 v/v). Detection was carried out with UV detector. The retention time was about 3.99 min; the method was validated for linearity, accuracy, precision, specificity, robustness and ruggedness. The described method shows excellent linearity over a range of 8-56 μg/mL for duloxetine. To establish stability indicating capability of the method, drug product was subjected to the stress condition of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from duloxetine. The developed method was validated as per ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

Key words: Duloxetine, validation, degradation, HPLC.