Abstract:
The aim of this study was to develop and validate an isocratic reversed phase high-performance liquid
chromatographic method for quantification of pizotifen malate in pharmaceutical solid dosage formulations.
Good chromatographic separation of pizotifen malate was achieved by using an analytical column, C18 ODS
column. The system was operated at 40°C oven temperature using a mobile phase consisting of acetonitrile and
acetate buffer pH 7.0 (60:40) at a flow rate of 2 ml/min. The method showed high sensitivity with good linearity
(r2
= 0.99997) over the tested concentration range of 0.0020 - 0.0300 mg/ml for pizotifen malate. Detection was
carried out at 231 nm and retention time was 2.838 min. Placebo and blank studies were performed and no peak
was observed at the retention time of pizotifen malate. The intermediate precision and accuracy results (mean ±
RSD, n=3) were (99.11±0.21) % and (99.19±0.55) % respectively with tailing factor (1.26±0.19). The proposed
method was validated in terms of selectivity, linearity, accuracy, precision, range, detection and quantitation
limit, system suitability and solution stability. This method can be successfully employed for simultaneous
quantitative analysis of pizotifen malate in pharmaceutical solid dosage formulations.
