Research Article | Volume: 3, Issue: 7, July, 2013
Research Article | Volume: 3, Issue: 7, July, 2013
A rapid, stability-indicating reversed phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of paliperidone palmitate (PP), in depot injectable dosage form. The chromatographic separation was achieved on an Acquity BEH C18 (50 mm × 2.1 mm, 1.7 µm) column, with a mobile phase consisting of ammonium acetate buffer, and acetonitrile at a ratio of 10:90 (v/v) and a flow rate of 0.6 mL/min. The eluted compound was monitored at a wavelength of 238 nm using a UV detector. The method described herein separated paliperidone palmitate from all other formulation components and two major known degradation products (N-Oxide and paliperidone) within a run time of 2.5 min. The method also generated linear results over a PP concentration range of 156 to 468 µg/mL. The stability indicating capability of the method was established by performing forced degradation experiments. The RP-UPLC method that was developed was validated according to the International Conference on Harmonization (ICH) guidelines. This method was successfully applied in the quantitative determination of PP in a stability study of paliperidone palmitate depot injection. The procedure described herein is simple, selective, and reliable for routine quality control analysis as well as stability testing.
Rakshit Kanubhai Trivedi, Prashant Jain , Mukesh C Patel , Parimal M Chatrabhuji , Dipika R Trivedi., A Rapid, Stability Indicating RP-UPLC Method for Determination of Paliperidone Palmitate in a Depot Injectable Formulation. J App Pharm Sci, 2013; 3 (07): 087-092.
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