Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume 41, Number 7, August 2003, pp. 381-384
Quantitation of Tolmetin by High-Performance Liquid Chromatography
and Method Validation
Fu-An Chen[1], Chau-Yang Chen[1], Chih-Jui Chen[2], and An-Bang
Wu[2]
[1]Department of Pharmacy, Tajen Institute of Technology, Pintung 90703, Taiwan,
and
[2]Graduate Institute of Pharmaceutical Sciences, Taipei Medical University,
Taipei 11031, Taiwan, R.O.C.
A high-performance liquid chromatographic (HPLC) assay method
for assessing the degradation of tolmetin (TLM) is developed and validated
under acidic, basic, and photoirradiated conditions. The HPLC method includes
an Inertsil 5 ODS-3V column (250- ¥ 4.6-mm i.d.), guard column of Inertsil
7 ODS-3V (50- ¥ 4.6-mm i.d.), mobile phase of CH3OH–1% HOAc (64:36,
v/v), and UV detection at 254 nm. The developed method satisfies the system
suitability criteria, peak integrity, and resolution for the parent drug and
its degradants. The established assay method exhibits good selectivity and
specificity suitable for stability measurements. From the intra- and interday
tests of six replicates, the coefficients of variation are between 0.20% and
1.77% for the former, and 0.12% and 3.40% for the latter. Recoveries are found
to be 98.7–101.7%. TLM is determined to be more reactive when exposed
to light and acidic conditions, yet TLM is stable in a basic medium. A kinetic
study of the photodegradation of TLM shows that it follows an apparent first-order
reaction in three alcoholic solvents.
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