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International Letters of Chemistry, Physics and Astronomy
Volume 59
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Development and Validation of a Headspace Gas Chromatographic Method for the Determination of Methyl Bromide Content in Itraconazole API
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Development and Validation of a Headspace Gas Chromatographic Method for the Determination of Methyl Bromide Content in Itraconazole API

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Abstract:

To provide quality control over the manufacture of any API, it is essential to develop highly selective analytical methods. Gas chromatography with headspace (HSGC) is widely used for the determination of residual impurities and solvents in API’s. In the current article we are reporting the development and validation of a rapid and specific Head space gas chromatographic (HSGC) method for the determination of methyl bromide in Itraconazole API. The developed method was validated in terms of specificity, linearity, precision, accuracy, limit of detection (LOD) and limit of quantitation (LOQ). The developed method was utilized for the investigation of methyl bromide content in bulk drug.

Info:

Periodical:
International Letters of Chemistry, Physics and Astronomy (Volume 59)
Pages:
160-169
DOI:
https://doi.org/10.18052/www.scipress.com/ILCPA.59.160
Citation:
M. Durga Babu et al., "Development and Validation of a Headspace Gas Chromatographic Method for the Determination of Methyl Bromide Content in Itraconazole API", International Letters of Chemistry, Physics and Astronomy, Vol. 59, pp. 160-169, 2015
Online since:
September 2015
Authors:
Mannem Durga Babu, Medikondu Kishore, K. Surendra Babu
Keywords:
Head Space Gas Chromatography, Method Development, Method Validation, Methyl Bromide
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Distribution:
Open Access

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This work is licensed under a
Creative Commons Attribution 4.0 International License

References:

[1] Sarvani Paruchuri et al. (Dec 2013) . A new development and validated RP-HPLC method for the assay and related substances of Itraconazole in capsule dosage form. Indian Journal of Research in Pharmacy and Biotechnology ISSN: 2321-5674(Print) ISSN: 2320 – 3471(Online).

[2] Waykar R et al. (May 2013) . Assessment of Genotoxic Impurities in Pharmaceuticals by In-Silico and In-Situ Derivatization-Headspace GC-MS Methodology. International Journal of Toxicological and Pharmacological Research 2013; 5(1): 33-41.

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DOI: https://doi.org/10.1590/s1984-82502011000200019

[4] B. Sivasaikiran et al. (Dec 2013). Determination by head space gas Chromatography with flame ionization detector in Ropinirole API. Int J Pharm Biomed Res 2013, 4(4), 227-230.

[5] Abhishek Gupta et al. (Feb 2010). Development and validation of a headspace gas chromatographic method for the determination of residual solvents in arterolane (RBx11160) maleate bulk drug. 10. 4103/0975- 7406. 62706 J Pharm Bioall Sci 2010; 2: 32-6.

DOI: https://doi.org/10.4103/0975-7406.62706

[6] Saravanan, R et al. (Oct 2011). Determination of Methyl Bromide at sub ppm Level in Finished Pharmaceutical Product by Gas Chromatography. International Journal of Current Research Vol. 3, Issue, 11, pp.400-404, October, (2011).

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