Next Article in Journal
Simultaneous Determination of Atorvastatin and Aspirin in Human Plasma by LC–MS/MS: Its Pharmacokinetic Application
Previous Article in Journal
Development of a Stability-Indicating RP-HPLC Method for the Determination of Rupatadine and its Degradation Products in Solid Oral Dosage Form
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Sci. Pharm.
Volume 80
Issue 4
10.3797/scipharm.1206-11
scipharm-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles thumb_up
...
Endorse textsms
...
Comment
Scientia Pharmaceutica is published by MDPI from Volume 84 Issue 3 (2016). Previous articles were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence, and they are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Austrian Pharmaceutical Society (Österreichische Pharmazeutische Gesellschaft, ÖPhG).
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

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

by
Pallavi VUKKUM
1,2,*,
Girish R. DESHPANDE
1,2,
J. Moses BABU
1,
R. MURALIKRISHNA
2 and
Pavani JAGU
1
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.
Sci. Pharm. 2012, 80(4), 903-922; https://doi.org/10.3797/scipharm.1206-11
Submission received: 19 June 2012 / Accepted: 27 July 2012 / Published: 27 July 2012
Versions Notes

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

Share and Cite

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. https://doi.org/10.3797/scipharm.1206-11

AMA Style

VUKKUM P, DESHPANDE GR, BABU JM, 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. Scientia Pharmaceutica. 2012; 80(4):903-922. https://doi.org/10.3797/scipharm.1206-11

Chicago/Turabian Style

VUKKUM, Pallavi, Girish R. DESHPANDE, J. Moses BABU, R. MURALIKRISHNA, and Pavani JAGU. 2012. "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" Scientia Pharmaceutica 80, no. 4: 903-922. https://doi.org/10.3797/scipharm.1206-11

APA Style

VUKKUM, P., DESHPANDE, G. R., BABU, J. M., MURALIKRISHNA, R., & JAGU, P. (2012). 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. Scientia Pharmaceutica, 80(4), 903-922. https://doi.org/10.3797/scipharm.1206-11

Article Metrics

Back to TopTop