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Volume 84
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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).
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Article

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

by
K. V. S. N. RAJU
1,*,
K. S. R. PAVAN KUMAR
1,*,
N. SIVA KRISHNA
1,
P. MADHAVA REDDY
1,
N. SREENIVAS
1,
Hemant KUMAR SHARMA
1,
G. HIMABINDU
2 and
N. ANNAPURNA
2
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.
Sci. Pharm. 2016, 84(2), 321-331; https://doi.org/10.3797/scipharm.1507-05
Submission received: 7 July 2015 / Accepted: 27 August 2015 / Published: 27 August 2015
Versions Notes

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

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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. https://doi.org/10.3797/scipharm.1507-05

AMA Style

RAJU KVSN, PAVAN KUMAR KSR, 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. Scientia Pharmaceutica. 2016; 84(2):321-331. https://doi.org/10.3797/scipharm.1507-05

Chicago/Turabian Style

RAJU, K. V. S. N., K. S. R. PAVAN KUMAR, N. SIVA KRISHNA, P. MADHAVA REDDY, N. SREENIVAS, Hemant KUMAR SHARMA, G. HIMABINDU, and N. ANNAPURNA. 2016. "Trace Level Determination of Mesityl Oxide and Diacetone Alcohol in Atazanavir Sulfate Drug Substance by a Gas Chromatography Method" Scientia Pharmaceutica 84, no. 2: 321-331. https://doi.org/10.3797/scipharm.1507-05

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