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Published on:15th July 2014
Indian Journal of Pharmaceutical Education and Research, 2014; 48(3):91-98
Pharmaceutical Research | doi:10.5530/ijper.48.3.11

A Simple, Novel Validated Stability Indicating RP-HPLC method for estimation of Duloxetine HCl in Capsule Pharmaceutical Formulation


Authors and affiliation (s):

Manisha Puranik*a, Sailesh Wadherb and Kritika Sharmaa

aInstitute of Pharmaceutical Education and Research, Wardha

bSchool of Pharmacy, Swami Raman and Teerth Marathwada University, Nanded

Abstract:

The object of current work was to study the degradation behavior of duloxetine under different ICH recommended stress condition under reverse phase high performance liquid chromatographic (HPLC) method and to establish a novel, validated stability-indicating reverse phase high performance liquid chromatographic method for the determination of duloxetine in presence of its impurities and forced degradation products in pharmaceutical formulation. The chromatographic separation was achieved on Hypersil, BDS- C8 , (250 mm × 4.6 mm, 5 μM) column with a mobile phase containing a mixture of Acetonitrile : Phosphate buffer pH 3.0 (50:50 v/v). Detection was carried out with UV detector. The retention time was about 3.99 min; the method was validated for linearity, accuracy, precision, specificity, robustness and ruggedness. The described method shows excellent linearity over a range of 8-56 μg/mL for duloxetine. To establish stability indicating capability of the method, drug product was subjected to the stress condition of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from duloxetine. The developed method was validated as per ICH guidelines with respect to specificity, linearity, LOD, LOQ, accuracy, precision and robustness.

Key words: Duloxetine, validation, degradation, HPLC.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs