Paliperidone Determination by Using HPLC Method in Blood Plasma Samples-Stability Indicating Method

Author(s): Manchuru Vanaja and J. Sreeramulu*

Abstract: Paliperidone product is used to control schizoaffective disorder in adults. In the market 3mg, 6mg, 9mg and 12mg strength tablet dosage form is available. Regular used strength tablets are 3mg and 6mg. Objective was to develop a simple HPLC method to evaluate the qualitative and quantitative quantity of the Paliperidone with known impurities separation. Blood plasma samples were prepared and injected into the HPLC. Simple HPLC method was developed and validated the method. Buffer: 2.1g of TBAHS in 100 mL of HPLC grade water, Mobile phase: Buffer, Acetonitrile 90:10 v/v, Zorbax SB C18 100 x 4.6 mm, 3.5 μm, flow rate 1.0 mL/min, 275 nm wavelength, 10 μL injection volume, column temperature 40°C were used. Run time 20 min was performed. Method validation was performed with precision, linearity, accuracy, ruggedness, robustness and specificity (interference and force degradation). Optimized method can be used to determine the Paliperidone in tablets dosage form.

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