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

A derivative UV spectrophotometric method for determination of paliperidone in OROS (R) 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, Delta lambda = 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 mu g 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 mu g mL(-1), respectively. When compared to HPLC, both methods proved to be adequate for determination of paliperidone in tablets.