Stability-Indicating HPTLC Method for Determination of Duloxetine Hydrochloride in Bulk Drug and Tablet Formulation

Abstract

A simple, accurate, precise, sensitive, selective, and stability-indicating high-performance thin-layer chromatographic method was developed and validated for determination of duloxetine hydrochloride both in bulk drug as well as in tablet formulation. The stationary phase used in our method consisted of HPTLC aluminum plates precoated with silica gel 60F-254, while, chloroform : methanol (8 : 2, v/v) was used as binary mobile phase. These chromatographic conditions eluted the drug effectively, and distinct compact spots were seen, (Rf, retardation factor, value (0.42 ± 0.20). Densitometric determination of duloxetine hydrochloride was carried out in the absorbance mode at a wavelength of 217 nm. The mean value of corelation coefficient; slope and intercept were 0.9962 ± 0.0015, 121.54 ± 0.61, and 987.3 ± 6.17, in the amount range of 600–2000 ng (nanogram) per spot, respectively. Stress testing validation were performed as per the guidelines of International Conference on Harmonization (ICH) and drug was subjected to stress conditions like acid-hydrolysis, alkali-hydrolysis, oxidation, and thermal degradation. As the method effectively separated the active drug from its degradation products, it can be employed as a stability-indicating assay method (SIAM) for identification and quantitative determination of duloxetine HCl in bulk drug and tablet dosage formulation.