A validated stability indicating rapid LC method for duloxetine HCl.
The present paper describes the development of a reversed phase liquid chromatographic (RPLC) analytical method for duloxetine HCl in the presence of its impurities and degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of duloxetine HCl was observed under acid hydrolysis. The drug was found to be stable in other stress conditions studied. Successful separation of the drug from the synthetic impurities and degradation products formed under stress conditions was achieved on a Zorabax XDB C18, 50 mm x 4.6 mm, 5.0 micron column using a mixture of aqueous 0.1% trifluroacetic acid, methanol, tetrahydrofuran (60:20:20, v/v/v) as mobile phase. The HPLC method developed was validated with respect to linearity, accuracy, precisions, specificity and ruggedness. To our knowledge, a rapid stability indicating LC method for duloxetine HCl has not been published elsewhere.
Srinivasulu
P
P
Department of Analytical Research and Development, Inogent Laboratories Pvt. Ltd., Hyderabad, India.
Srinivas
K S V
KS
Reddy
R S
RS
Mukkanti
K
K
Buchireddy
R
R
D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D000068736:Duloxetine Hydrochloride; D006358:Hot Temperature; D006868:Hydrolysis; D007202:Indicators and Reagents; D018697:Nootropic Agents / Q000032:analysis*; D010084:Oxidation-Reduction; D010782:Photolysis; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013876:Thiophenes / Q000032:analysis*
D007202:Indicators and Reagents; D018697:Nootropic Agents; D012996:Solutions; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride