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Volume 78
Issue 4
10.3797/scipharm.1009-11
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Article

Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form

by
Usmangani K. CHHALOTIYA
*,
Kashyap K. BHATT
,
Dimal A. SHAH
and
Sunil L. BALDANIA
Indukaka Ipcowala College of Pharmacy, Beyond GIDC Phase IV, Vithal Udyognagar, New Vallabh Vidyanagar-388121, Anand, Gujarat, India
*
Author to whom correspondence should be addressed.
Sci. Pharm. 2010, 78(4), 857-868; https://doi.org/10.3797/scipharm.1009-11
Submission received: 25 September 2010 / Accepted: 25 October 2010 / Published: 25 October 2010
Versions Notes

Abstract

The objective of the present work was to develop a stability-indicating RP-HPLC method for duloxetine hydrochloride (DUL) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid hydrolysis. The drug was found to be stable to dry heat, photodegradation, oxidation and basic condition attempted. Successful separation of the drug from the degradation products formed under acidic stress conditions was achieved on a Hypersil C-18 column (250 mm X 4.6 mm id, 5μm particle size) using acetonitrile: 0.01 M potassium dihydrogen phosphate buffer (pH 5.4 adjusted with orthophosphoric acid) (50:50, v/v) as the mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with photodiode array detection at 229 nm over the concentration range 1–25 μg/ml with range of recovery 99.8–101.3 % for DUL by the RP-HPLC method. Statistical analysis proved the method to be repeatable, specific, and accurate for estimation of DUL. It can be used as a stabilityindicating method due to its effective separation of the drug from its degradation products.
Keywords: RP-HPLC; Duloxetine hydrochloride; Validation; Stress conditions; Degradants RP-HPLC; Duloxetine hydrochloride; Validation; Stress conditions; Degradants

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MDPI and ACS Style

CHHALOTIYA, U.K.; BHATT, K.K.; SHAH, D.A.; BALDANIA, S.L. Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form. Sci. Pharm. 2010, 78, 857-868. https://doi.org/10.3797/scipharm.1009-11

AMA Style

CHHALOTIYA UK, BHATT KK, SHAH DA, BALDANIA SL. Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form. Scientia Pharmaceutica. 2010; 78(4):857-868. https://doi.org/10.3797/scipharm.1009-11

Chicago/Turabian Style

CHHALOTIYA, Usmangani K., Kashyap K. BHATT, Dimal A. SHAH, and Sunil L. BALDANIA. 2010. "Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form" Scientia Pharmaceutica 78, no. 4: 857-868. https://doi.org/10.3797/scipharm.1009-11

APA Style

CHHALOTIYA, U. K., BHATT, K. K., SHAH, D. A., & BALDANIA, S. L. (2010). Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form. Scientia Pharmaceutica, 78(4), 857-868. https://doi.org/10.3797/scipharm.1009-11

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