Development and validation of stability indicating spectrophotometric and HPTLC methods for determination of acemetacin
Open Access
- 30 June 2014
- journal article
- Published by European Journal of Chemistry in European Journal of Chemistry
- Vol. 5 (2), 219-226
- https://doi.org/10.5155/eurjchem.5.2.219-226.966
Abstract
Three simple and sensitive methods were developed for the determination of acemetacin (ACM) in presence of its degradation product, indomethacin (DEG). Several methods were evaluated and are presented. Method A was based on measuring the peak amplitude of the first derivative of the ratio spectra 1DD at 244 nm. In method B, mean centering of ratio spectra method (MCR) was applied, which depends on measuring the mean centered values of ratio spectra of ACM at 234 nm. Method C provided separation of ACM from its DEG on pre-activated silica gel 60F254 HPTLC plates using hexane:ethyl acetate:glacial acetic acid (6:4:0.3, v:v:v) as developing system followed by scanning at 254 nm. The suggested methods were validated in compliance with the International Conference on Harmonisation (ICH) guidelines and were successfully applied for quantification of ACM in its commercial capsule. The proposed methods were also statistically compared to a reported HPLC method with no significant difference in performance; indicating the ability of the proposed method to be reliable and suitable for routine analysis of drug product.Keywords
This publication has 11 references indexed in Scilit:
- Mechanisms underlying the anti-inflammatory activity and gastric safety of acemetacinBritish Journal of Pharmacology, 2007
- Mean centering of ratio spectra as a new spectrophotometric method for the analysis of binary and ternary mixturesTalanta, 2005
- Pharmacokinetics of Indomethacin, a Metabolite of Acemetacin, Following a Single dose and Multiple doses Administered as Acemetacin Sustained-Release Tablets in Healthy Male VolunteersJournal of Health Science, 2005
- Mean centering of ratio kinetic profiles as a novel spectrophotometric method for the simultaneous kinetic analysis of binary mixturesAnalytica Chimica Acta, 2004
- Development of validated stability-indicating assay methods—critical reviewJournal of Pharmaceutical and Biomedical Analysis, 2002
- Quality control of pharmaceuticals containing non-steroidal anti-inflammatory drugs by micellar liquid chromatographyChromatographia, 2002
- Interaction of drugs with hexadecylphosphocholine micelles. Derivative spectroscopy, acid–base and solubility studiesMaterials Science and Engineering: C, 2001
- An optimization procedure for determination of indomethacin and acemethacin by differential pulse adsorptive stripping voltammetry. Application on urine samplesTalanta, 1998
- Genetic-algorithm-based wavelength selection in multicomponent spectrometric determinations by PLS: application on indomethacin and acemethacin mixtureAnalytica Chimica Acta, 1997
- Acemetacin and indomethacin in the treatment of rheumatoid arthritis: A double-blind comparative study in general practiceCurrent Medical Research and Opinion, 1991