Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
46, Number 5, May/June 2008, pp. 440-444
A Simple and Sensitive Stability-Indicating RP-HPLC
Assay Method for the Determination of Aceclofenac
J.R. Bhinge1,2 , R.V. Kumar1,2,
and V.R. Sinha1,
1University Institute of Pharmaceutical Sciences, Panjab University,
Chandigarh-160014 and
2Center with Potential for Excellence
in Biomedical Sciences, Panjab University, Chandigarh-160014
The aim of the present study is to develop a stability-indicating
assay method for the determination of aceclofenac after being
subjected to different International Conference on Harmonization
prescribed stress conditions, such as hydrolysis, oxidation,
heat, and photolysis. Aceclofenac (2-[2-[2-(2,6-dichlorophenyl)aminophenyl]acetyl]oxyacetic
acid) is decomposed under hydrolytic stress (neutral, acidic,
and alkaline) and also on exposure to light (in solution form).
The compound is stable to oxidative stress, heat, and photolytic
stress (in solid form). The major degradation product is diclofenac,
which is confirmed through comparison with the standard. Separation
of the drug from major and minor degradation products is achieved
on a C-18 column using methanol–0.02% of ortho phosphoric
acid in a ratio of 70:30. The method is linear over the concentration
range of 1–100 µg/mL (r2 = 0.9988). The
detection wavelength is 275 nm. The method is validated for linearity,
range, precision, accuracy, specificity, and selectivity.
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