Stability-Indicating HPTLC Methods for Determination of Milnacipran HCl, Duloxetine HCl, and Pregabalin in Bulk Drug and Pharmaceutical Formulations

Author(s): Maha Farouk Abdel-Ghany, Omar Abdel-Aziz and Eman Wafik Eskander

The present study describes the development and subsequent validation of stability-indicating methods for determination of Milnacipran HCl 'A', Duloxetine HCl 'B', and Pregabalin 'C' each in the presence of its degradation products, using high-performance thin layer chromatographic techniques (HPTLC). The chromatographic development was carried out on HPTLC plates precoated with silica gel 60 F254 using a mixture of acetonitrile-water-ammonia (6+0.6+1.6, v/v/v) as a mobile phase for A, dichloromethane-methanol (8+1, v/v) as a mobile phase for B, and ethyl acetate-methanol-ammonia (6+3+0.1, v/v/v) as a mobile phase for C. Detection was carried out densitometrically at wavelength "220, 230, and 210 nm" respectively. The utilized chromatographic methods were validated according to the international conference on harmonization (ICH) guidelines and successfully applied for determination of the studied drugs in pure form, and in pharmaceutical formulations with good extraction recoveries. All the results were statistically compared with reference methods, where there were no significant differences found. The developed methods were satisfactorily applied to analysis of the investigated drugs and proved to be specific and accurate for quality control procedures in pharmaceutical formulations.

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