Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
47, Number 7, August 2009, pp. 599-604
Development and Validation of a Stability-Indicating
Method for the Quantitation of Paclitaxel in Pharmaceutical Dosage
Forms
Ali Mohammadi1,2, Farnaz Esmaeili3,
Rasoul Dinarvand3,
Fatemeh Atyabi3, and Roderick B. Walker4
1Department of Drug and Food Control, Faculty of Pharmacy, Tehran
University of Medical Sciences, P.O. Box 14155-6451, Tehran 14174, Iran;
2Pharmaceutical sciences Research Center, Tehran University of Medical
Sciences, Tehran, Iran;
3Medical Nanotechnology Research Center, Faculty
of Pharmacy, Tehran University of Medical Sciences, P.O. Box 14155-6451,
Tehran 14174, Iran;
4Department of Pharmaceutics, Faculty of Pharmacy,
Rhodes University, Grahamstown, South Africa
A simple, rapid stability-indicating isocratic
assay has been developed and validated for the determination
of Paclitaxel (PTX) in commercial injection formulations. The
assay is performed using a Nucleosil RP-18 (5 µm, 250 × 4.0
mm i.d) column protected by a Nucleosil C18 precolumn (5 µm,
4.0 × 4.0 mm i.d.) with a mobile phase of methanol–water
(80:20) and UV detection at 230 nm. The method was found to be
specific for PTX in the presence of degradation products with
an overall analytical run time of ~ 9 min. Accuracy reported
as % bias was found to be 0.1–2.5% bias for all samples
tested. Intra-assay precision (repeatability) was found to be
0.22–2.65% RSD, while inter-day precision (intermediate
precision) was found to be 1.0–3.0% RSD for the samples
studied. The calibration curve was found to be linear with the
equation y = 29.78x + 7.65, and a linear regression
coefficient of 0.9994 over the concentration range 0.05–20 µg/mL.
The limits of quantitation and detection were 0.05 and 0.02 µg/mL,
respectively. Taxol (30 mg/5 mL), a commercially available dosage
form of PTX, was assayed and 100.6–103.6% of the label
claim was recovered.
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