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The development of the spectrofotometric and HPLC method for studying enteric coated capsules containing Duloxetine Hydrochloride active substance

Sławek Wicherkiewicz ,  Magdalena M. Dąbrowska 

Instytut Farmaceutyczny (PRI), Rydygiera 8, Warszawa 01-793, Poland


The aim of this work was to develop analytical methods used for studying enteric coated capsules with Duloxetine Hydrochloride – an antidepressant drug.

The reference product was Cymbalta 30 mg, 60 mg capsules manufactured by ELI LILLY Nederland B. V.

The RP-HPLC and spectrophotometric methods were developed for the study of the assay & quantity of the active substance released from the drug form. The above methods were then compared.

The dissolution profiles were determined through the use of spectrophotometric and RP-HPLC methods and compared using the similarity factor f2 in relation to the reference batch, in the range from the time point 5 minutes to the point when the active substance release was above 85%.

The   similarity factors f2 amounted to above 50 proving that the dissolution profiles were similar. Both methods can be used for the determination of duloxietine content in the tested capsules with Duloxetine.


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Related papers

Presentation: Poster at VII Multidyscyplinarna Konferencja Nauki o Leku, by Sławek Wicherkiewicz
See On-line Journal of VII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2010-03-30 12:24
Revised:   2010-04-08 11:40