Abstract
A derivative UV spectrophotometric method for determination of paliperidone in OROS® tablets was validated and compared to a previously validated HPLC. The parameters specificity, linearity, precision, accuracy, LOD and LOQ were studied according to official guidelines. The first-order derivative spectra were obtained at N = 5, Δλ= 1.0 nm, and determinations were made at 288 nm. The drug was extracted from osmotic tablets by using 0.1 M HCl as solvent, and ultrasonic bath. The proposed method showed specificity and linearity in the concentration range of 40.0 to 80.0 μg mL-1 The intra and interday precision data demonstrated that the method has good reproducibility. The drug content on the formulation was ranged from 101.84 to 102.76%. Accuracy was also evaluated and results were found to be satisfactory. The detection and quantitation limits were 0.85 and 2.59 μg mL-1, respectively. When compared to HPLC, both methods proved to be adequate for determination of paliperidone in tablets.
Keywords: Extraction procedure, derivative UV spectrophotometry, OROS® tablets, paliperidone, quantitative determination, validation.
Current Analytical Chemistry
Title:Quantitative Determination of Paliperidone in OROS® Tablets by Derivative Spectrophotometric Method – Application in Extraction and Comparison to HPLC
Volume: 10 Issue: 1
Author(s): Andreas S. L. Mendez, José Pedro E. Cassol, Vanessa Brum de Camargo, Marcelo Donadel Malesuik and Cássia V. Garcia
Affiliation:
Keywords: Extraction procedure, derivative UV spectrophotometry, OROS® tablets, paliperidone, quantitative determination, validation.
Abstract: A derivative UV spectrophotometric method for determination of paliperidone in OROS® tablets was validated and compared to a previously validated HPLC. The parameters specificity, linearity, precision, accuracy, LOD and LOQ were studied according to official guidelines. The first-order derivative spectra were obtained at N = 5, Δλ= 1.0 nm, and determinations were made at 288 nm. The drug was extracted from osmotic tablets by using 0.1 M HCl as solvent, and ultrasonic bath. The proposed method showed specificity and linearity in the concentration range of 40.0 to 80.0 μg mL-1 The intra and interday precision data demonstrated that the method has good reproducibility. The drug content on the formulation was ranged from 101.84 to 102.76%. Accuracy was also evaluated and results were found to be satisfactory. The detection and quantitation limits were 0.85 and 2.59 μg mL-1, respectively. When compared to HPLC, both methods proved to be adequate for determination of paliperidone in tablets.
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Cite this article as:
Mendez S. L. Andreas, Cassol Pedro E. José, Camargo Brum de Vanessa, Malesuik Donadel Marcelo and Garcia V. Cássia, Quantitative Determination of Paliperidone in OROS® Tablets by Derivative Spectrophotometric Method – Application in Extraction and Comparison to HPLC, Current Analytical Chemistry 2014; 10 (1) . https://dx.doi.org/10.2174/1573411011410010014
DOI https://dx.doi.org/10.2174/1573411011410010014 |
Print ISSN 1573-4110 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-6727 |
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