Next Article in Journal
Development and Validation of Rapid RP-HPLC-DAD Analysis Method for Simultaneous Quantitation of Paclitaxel and Lapatinib in Polymeric Micelle Formulation
Previous Article in Journal
Development of a Stability-Indicating Stereoselective Method for Quantification of the Enantiomer in the Drug Substance and Pharmaceutical Dosage Form of Rosuvastatin Calcium by an Enhanced Approach
Article Menu

Article Versions

Export Article

Open AccessArticle
Sci. Pharm. 2016, 84(2), 321-331; doi:10.3797/scipharm.1507-05

Trace Level Determination of Mesityl Oxide and Diacetone Alcohol in Atazanavir Sulfate Drug Substance by a Gas Chromatography Method

1
Aurobindo Pharma Limited Research Centre-II, Survey No. 71&72, Indrakaran Village, Sangareddy Mandal, Medak-502329, Andhra Pradesh, India
2
Department of Engineering Chemistry, AU college of Engineering, Andhra University, Visakhapatnam-530003, Andhra Pradesh, India
*
Authors to whom correspondence should be addressed.
Received: 7 July 2015 / Accepted: 27 August 2015 / Published: 27 August 2015
Download PDF [162 KB, uploaded 7 September 2016]

Abstract

A capillary gas chromatography method with a short run time, using a flame ionization detector, has been developed for the quantitative determination of trace level analysis of mesityl oxide and diacetone alcohol in the atazanavir sulfate drug substance. The chromatographic method was achieved on a fused silica capillary column coated with 5% diphenyl and 95% dimethyl polysiloxane stationary phase (Rtx-5, 30 m x 0.53 mm x 5.0 µm). The run time was 20 min employing programmed temperature with a split mode (1:5) and was validated for specificity, sensitivity, precision, linearity, and accuracy. The detection and quantitation limits obtained for mesityl oxide and diacetone alcohol were 5 µg/g and 10 µg/g, respectively, for both of the analytes. The method was found to be linear in the range between 10 µg/g and 150 µg/g with a correlation coefficient greater than 0.999, and the average recoveries obtained in atazanavir sulfate were between 102.0% and 103.7%, respectively, for mesityl oxide and diacetone alcohol. The developed method was found to be robust and rugged. The detailed experimental results are discussed in this research paper.
Keywords: Mesityl oxide; Diacetone alcohol; Atazanavir sulfate; GC-FID; Development; Validation Mesityl oxide; Diacetone alcohol; Atazanavir sulfate; GC-FID; Development; Validation
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).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

RAJU, K.V.S.N.; PAVAN KUMAR, K.S.R.; SIVA KRISHNA, N.; MADHAVA REDDY, P.; SREENIVAS, N.; KUMAR SHARMA, H.; HIMABINDU, G.; ANNAPURNA, N. Trace Level Determination of Mesityl Oxide and Diacetone Alcohol in Atazanavir Sulfate Drug Substance by a Gas Chromatography Method. Sci. Pharm. 2016, 84, 321-331.

Show more citation formats Show less citations formats

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Sci. Pharm. EISSN 2218-0532 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top