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Validation and application of reversed phase high-performance liquid chromatographic method for quantification of Pizotifen malate in pharmaceutical solid dosage formulations

Author(s)
Shaikh Mukidur Rahman Department of Pharmaceutical Technology, University of Dhaka, Dhaka, Bangladesh
Abul Kabir Kalam Department of Pharmaceutical Technology, University of Dhaka, Dhaka, Bangladesh
Shamsur Rouf Department of Pharmaceutical Technology, University of Dhaka, Dhaka, Bangladesh
Arshad Jahan Department of Product Development, Square Pharmaceuticals Ltd, Kaliakoir, Gazipur, Bangladesh
Azm Ruhul Momen Department of Pharmacy, Jagannath University, Dhaka, Bangladesh
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.
Publication Details
Page(s) 435-441
DOI DOI not available
Published Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 23, Issue: 4, Year: 2010

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