METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ARTEROLANE MALEATE AND PIPERAQUINE PHOSPHATE BY RP-HPLC

摘要

A novel, precise, accurate, rapid and cost effective isocratic reverse-phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the estimation of Arterolane maleate and Piperaquine phosphate in pharmaceutical dosage forms (tablet). The drugs were estimated using hypersil C18 (250 mm x 4.6 mm i.d- 5 μm particle size) column. A mobile phase composed of phosphate buffer, acetonitrile, methanol in proportion of 40:30:30 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 244 nm. The linearity range obtained was 20-70 μg/ml for ART and 100-350 μg/ml for PIP with retention times (_Rt) of 3.353 min and 2.389 min for ART and PIP respectively. The correlation coefficient values were found to be 0.999. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of ART and PIP were in the range of 99.47-100.72% and 99.30-100.18% respectively. The assay results of ART and PIP were 99.57% and 99.75 % respectively. The limit of detection (LOD) and limit of quantification (LOQ) were 0.172 μg/ml 0.524 μg/ml for ART and 0.542 μg/ml and 1.641 μg/ml for PIP respectively. The method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.