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Stability-indicating RP-HPLC method development and validation for duloxetine hydrochloride in tablets
Sejal K Patel1, Natavarlal J Patel, Arun M Prajapati
1Ganpat University, S.K. Patel College of Pharmaceutical Education and Research, Department of Pharmaceutical Chemistry, Kherva-382711, Mehsana, Gujarat, India. skpatel_2@rediffmail.com
A new stability-indicating RP-HPLC method was developed for duloxetine hydrochloride (DLX). This method accurately quantifies DLX and its degradation products, ensuring drug quality and safety.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Duloxetine hydrochloride (DLX) requires robust analytical methods for quality control.
- Forced decomposition studies are crucial for understanding drug stability and developing stability-indicating methods.
Purpose of the Study:
- To develop and validate a stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for duloxetine hydrochloride.
- To assess the stability of DLX under various stress conditions.
Main Methods:
- RP-HPLC using a Phenomenex C18 column.
- Acetonitrile-methanol-ammonium acetate buffer mobile phase.
- Photodiode array (PDA) detection at 290 nm.
Main Results:
- DLX degraded under acid, base, oxidative, wet heat, and photolytic conditions, but was stable to dry heat.
- The developed RP-HPLC method successfully separated DLX from its degradation products.
- The method demonstrated high accuracy (101.048 +/- 0.53% recovery) and precision.
Conclusions:
- The developed RP-HPLC method is stability-indicating, specific, accurate, and repeatable for DLX estimation.
- This method is suitable for routine quality control and stability testing of duloxetine hydrochloride.
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