ABSTRACT

A fast, precise, and simple Reverse Phase High-Performance Liquid Chromatographic method (RP-HPLC) has been developed for the determination of Duloxetine Hydrochloride in the pharmaceutical dosage form. The chromatographic separation was done using Eclipse Plus C18 column (250 mm X 4.6 mm, 5 ?m particle size) as a stationary phase with a mobile phase comprising of Phosphate Buffer:Acetonitrile: Methanol (50:30:20 v/v/v) adjust pH to 4.9 with dilute acetic acid at a flow rate of 1.0 mL/min., column temperature of 25 ± 1oC and UV detection at 231nm. The retention time of Duloxetine Hydrochloride was 11.03 minutes. The linearity was found to be in the range of 12-60 ?g/mL with a correlation coefficient of 0.9997. The stated method was validated as per ICH Q2 (R1) guidelines and can be effectively applied for the determination of Duloxetine Hydrochloride in marketed formulations. Keywords: Duloxetine Hydrochloride, RP-HPLC, Pharmaceutical Formulation, Validation
Publication date: 01/05/2023

https://ijbpas.com/pdf/2023/May/MS_IJBPAS_2023_7013.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.5.7013