GET THE APP

Novel analytical method development and validation for the determination of residual solvents in amlodipine besylate by gas chromatography | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission Systemof respective journal.

Abstract

Novel analytical method development and validation for the determination of residual solvents in amlodipine besylate by gas chromatography

Author(s): V. Anil Kumar, G. Aravind, I. Srikanth,A. Srinivasarao, Ch. Dharma Raju

The purpose of this research study was to develop and optimize an accurate and precise GC method for the determination of Residual solvents (n-Hexane, Methanol, Isopropyl Alcohol, Toluene, O-Xylene, DMF & Acetic acid) in Amoldipine besylate using the DB-FFAP, 30 m x 0.53mm ID, 1.0 μm column as stationary phase. The injection volume of samples taken is 1 μl. The split ratio of the injection was 1:10. The temperature maintained at the injector and detector was to be 220ºC and 260ºC respectively. Nitrogen gas having make up flow 40 ml/ minute and having column flow 2.8 ml/minute used as mobile phase and the detection was by FID. The flow of hydrogen and Air was maintained at 30ml/min and 300ml/min respectively. The diluent used is Dimethyl Sulfoxide. All solvents well resolved each other with diluents peak RT at 21 min in total run time of 24.25 min. The RTs observed for the Residual solvents n-Hexane, Methanol, Isopropyl Alcohol, Toluene, O-Xylene, DMF & Acetic acid are 3.03, 6.20, 6.87, 10.27, 14.57, 17.49 &19.54 respectively. The method was validated as meets the all regulations of System suitability, Specificity, Method Precision, Linearity, LOD & LOQ, Precision of LOQ and Accuracy/Recovery under ICH specifications.


PDF

Select your language of interest to view the total content in your interested language

30+ Million Readerbase
SCImago Journal & Country Rank
Google Scholar citation report
Citations : 25868

Der Pharma Chemica received 25868 citations as per Google Scholar report

Der Pharma Chemica peer review process verified at publons
Der Pharma Chemica- Journals on pharmaceutical chemistry