A validated stability indicating high performance liquid chromatographic assay method for simultaneous determination of citicoline and piracetam in tablet formulation

Research Article

Sanjaykumar B. Bari, Gopal O.

Abstract

A simple, reliable and stability indicating reversed-phase high-performance liquid chromatographic method has been developed and validated for the simultaneous determination of citicoline and piracetam in their synthetic mixtures and combined tablet formulations. Both drugs were separated on a Chromatopak C18 250 mm × 4.6mm Column packed with 10μm particles. The optimized mobile phase was a 90:10 (v/v/v) mixture of 10 mM potassium phosphate buffer (pH 3.5), pumped at a flow rate of 0.8 ml/min. UV detection was performed at 215 nm. The method was validated in the concentration ranges of 17.5-32.5μg/ml for citicoline and 28-52μg/ml for piracetam, where it demonstrated good linearity with r2= 0.999 and 0.998 (n = 3), respectively. The method demonstrated to be robust, resisting to small deliberate changes in pH, flow rate and composition (buffer: organic ratio) of the mobile phase. The applicability of the method was demonstrated by determining the drug content of commercial pharmaceutical formulations, where it exhibited good performance.

Relevant Publications in Der Pharmacia Lettre