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Analytical Method Development and Validation for the Quantification of Acetone and Isopropyl Alcohol in the Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using Headspace Gas Chromatographic Technique
Joint Authors
Valavala, Sriram
Seelam, Nareshvarma
Tondepu, Subbaiah
Jagarlapudi, V. Shanmukha Kumar
Sundarmurthy, Vivekanandan
Source
Journal of Analytical Methods in Chemistry
Issue
Vol. 2018, Issue 2018 (31 Dec. 2018), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2018-03-01
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
A simple, sensitive, accurate, robust headspace gas chromatographic method was developed for the quantitative determination of acetone and isopropyl alcohol in tartaric acid-based pellets of dipyridamole modified release capsules.
The residual solvents acetone and isopropyl alcohol were used in the manufacturing process of the tartaric acid-based pellets of dipyridamole modified release capsules by considering the solubility of the dipyridamole and excipients in the different manufacturing stages.
The method was developed and optimized by using fused silica DB-624 (30 m × 0.32 mm × 1.8 µm) column with the flame ionization detector.
The method validation was carried out with regard to the guidelines for validation of analytical procedures Q2 demanded by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
All the validation characteristics were meeting the acceptance criteria.
Hence, the developed and validated method can be applied for the intended routine analysis.
American Psychological Association (APA)
Valavala, Sriram& Seelam, Nareshvarma& Tondepu, Subbaiah& Jagarlapudi, V. Shanmukha Kumar& Sundarmurthy, Vivekanandan. 2018. Analytical Method Development and Validation for the Quantification of Acetone and Isopropyl Alcohol in the Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using Headspace Gas Chromatographic Technique. Journal of Analytical Methods in Chemistry،Vol. 2018, no. 2018, pp.1-10.
https://search.emarefa.net/detail/BIM-1176562
Modern Language Association (MLA)
Valavala, Sriram…[et al.]. Analytical Method Development and Validation for the Quantification of Acetone and Isopropyl Alcohol in the Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using Headspace Gas Chromatographic Technique. Journal of Analytical Methods in Chemistry No. 2018 (2018), pp.1-10.
https://search.emarefa.net/detail/BIM-1176562
American Medical Association (AMA)
Valavala, Sriram& Seelam, Nareshvarma& Tondepu, Subbaiah& Jagarlapudi, V. Shanmukha Kumar& Sundarmurthy, Vivekanandan. Analytical Method Development and Validation for the Quantification of Acetone and Isopropyl Alcohol in the Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using Headspace Gas Chromatographic Technique. Journal of Analytical Methods in Chemistry. 2018. Vol. 2018, no. 2018, pp.1-10.
https://search.emarefa.net/detail/BIM-1176562
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1176562