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Sci. Pharm. 2012, 80(4), 903-922; doi:10.3797/scipharm.1206-11

Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination of Abacavir, its Related Substances, and Degradation Products

1
Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories Ltd., Bollaram road, Miyapur, Hyderabad-500049 (AP), India
2
Department of Chemistry, Andhra University, Visakhapatnam-530003, India
*
Author to whom correspondence should be addressed.
Received: 19 June 2012 / Accepted: 27 July 2012 / Published: 27 July 2012
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Abstract

A novel, stability-indicating UHPLC method was developed for the quantitative determination of Abacavir sulfate, its related substances, and forced degra-dation impurities in bulk drugs. The chromatographic separation was achieved on a Waters Acquity BEH C8, 50 mm × 2.1 mm, 1.7 μm particle size column with a mobile phase containing a gradient mixture of solution A (0.10 % v/v o-phosphoric acid in water) and solution B (0.10% v/v o-phosphoric acid in methanol). The flow rate was set at 0.40 mL/min and the run time was 6.0 min. The drug substance was subjected to the stress studies of hydrolysis, oxidation, photolysis, and thermal degradation. Abacavir sulfate was found to degrade significantly under acidic hydrolysis and oxidative stress conditions. The formed degradation products were reported and were well-resolved from Abacavir and its related substances. The mass balance was found to be satisfactory in all of the stress conditions, thus proving the stability-indicating capability of the method. The developed UHPLC method was validated to be in agreement with ICH requirements and found to be rapid, accurate, precise, linear, specific, and suitable for the quantitative determination of related substances and degradants in the bulk drug samples of Abacavir sulfate.
Keywords: Abacavir Sulfate; UHPLC; Forced degradation; Identification; Validation; LC-MS Abacavir Sulfate; UHPLC; Forced degradation; Identification; Validation; LC-MS
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

VUKKUM, P.; DESHPANDE, G.R.; BABU, J.M.; MURALIKRISHNA, R.; JAGU, P. Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination of Abacavir, its Related Substances, and Degradation Products. Sci. Pharm. 2012, 80, 903-922.

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