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.
