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

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...

Full description

Saved in:
Bibliographic Details
Published in:Journal of analytical methods in chemistry 2018-01, Vol.2018 (2018), p.1-10
Main Authors: Jagarlapudi, V. Shanmukha Kumar, Tondepu, Subbaiah, Seelam, Nareshvarma, Valavala, Sriram, Sundarmurthy, Vivekanandan
Format: Article
Language:English
Subjects:
Acceptance criteria
Acetone
Acids
Alcohol
Alcohols
Analysis
Aspirin
Chromatography
Detectors
Dipyridamole
Drug dosages
drugs
Flame ionization
Flame ionization detectors
Fused silica
Gas chromatography
Gas flow
guidelines
headspace analysis
humans
Ionization
Ionization counters
Isopropanol
isopropyl alcohol
manufacturing
Methods
Pellets
Pharmaceutical sciences
Pharmacy
quantitative analysis
Sensors
silica
Silicon dioxide
solubility
solvents
Tartaric acid
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:2090-8865
2090-8873
2090-8873
DOI:10.1155/2018/8240932