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Quantitative Determination of Paliperidone in OROS® Tablets by Derivative Spectrophotometric Method – Application in Extraction and Comparison to HPLC

[ Vol. 10 , Issue. 1 ]

Author(s):

Andreas S. L. Mendez, José Pedro E. Cassol, Vanessa Brum de Camargo, Marcelo Donadel Malesuik and Cássia V. Garcia   Pages 158 - 165 ( 8 )

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.

Affiliation:

BR 472 Km 585 Prédio Administrativo CEP 97500-970, Uruguaiana-RS, Brazil.



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