Validation and application of reversed phase high-performance liquid chromatographic method for quantification of pizotifen malate in pharmaceutical solid dosage formulations.
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, C(18) 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 (r(2)= 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.
Rahman
Shaikh Mukidur
SM
Department of Pharmaceutical Technology, University of Dhaka, Dhaka-1000, Bangladesh.
Lutfulkabir
Abulkalam
A
Jahan
M D Arshad
MD
Momen
A Z M Ruhul
AZ
Rouf
Abushara Shamsur
AS
D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004304:Dosage Forms; D007202:Indicators and Reagents; D010918:Pizotyline / Q000032:analysis*; D012044:Regression Analysis; D015203:Reproducibility of Results; D012702:Serotonin Antagonists / Q000032:analysis*; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
D004304:Dosage Forms; D007202:Indicators and Reagents; D012702:Serotonin Antagonists; D012996:Solutions; D010918:Pizotyline