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Analysis of Pramipexole dihydrochloride by Vis-Spectrophotometric methods: Development and Validation

Author(s): Petikam Lavudu1*, Chandra Bala Sekaran2, Nallani Gayathri 3, Tumpara Srinu3,Avula Prameela Rani4

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 5;
Start page: 1493;
Date: 2011;
Original page

Keywords: Pramipexole | 1 | 10-Phenanthroline | 2 | 2'-Bipyridyl | Prussian blue | Analysis.

Three simple, sensitive and accurate vis-spectrophotometric methods were developed for the determination of pramipexole dihydrochloride in bulk and tablet dosage forms The methods (A & B) are based on the oxidation of pramipexole dihydrochloride with iron(III) and the subsequent formation of an intensive orange red complex between the liberated iron(II) and 1,10- phenanthroline (method A) or 2,2'-bipyridyl (method B) reagents. Method C is based on the fact that iron(III) is reduced to iron(II) by pramipexole dihydrochloride, then the in situ formed iron(II) reacts with potassium ferricyanide to give the soluble Prussian blue in acidic conditions. By measuring the absorbance of iron(II)-1,10-phenanthroline complex, iron(II)-2,2'-bipyridyl and soluble Prussian blue at the absorption maximum of 530, 530 and 735 nm, respectively, the indirect determination of pramipexole dihydrochloride can be obtained. A good linear relationship of the concentration of pramipexole dihydrochloride versus absorbance is observed with a linear range of 4-40, 3-30 and 2-20 μg mL-1 for methods A, B and C, respectively. The methods were successfully applied to the determination of pramipexole dihydrochloride in tablet dosage forms. The results were statistically compared with those of a literature method by applying the Students t-test and F-test. No interference was observed from the excipients normally added to tablet dosage forms. The validity of the methods was further ascertained by performing recovery experiments via standard-addition method.
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