A Validated Stability-Indicating Hplc Assay Method For Piperaquine Phosphate In Bulk Drug

Abstract

A new simple, reliable, inexpensive, and accurate reversed phase-high performance liquid- chromatographic (HPLC) assay method was developed and validated for the simultaneous quantitative determination of Piparaquine Phosphate in bulk drug. Piparaquine Phosphate is an orally active bisquinoline antimalarial drug and shows good activity against chloroquine resistant plasmodium strains. Method developed with column Waters Xterra, RP18, with dimension 250 x

4.6mm 5µm. The mobile phase containing 2.84 gm of di-sodium hydrogen phosphate was dissolved in water and 1ml of triethyl amine was added. The pH was Adjusted 7.0 with orthophosphoric acid. The buffer: acitonitrile ratio used was 30:70. The flow rate was 1.0 mL/min, column temperature was 25°C and effluents were monitored at wavelength 320 nm. The retention time of Piperaquine Phosphate was 5.6 min. Correlation co-efficient for Piperaquine Phosphate was found to be 0.99. The novel stability indicating developed method was validated as per the ICH guidelines using various parameters, for example, accuracy, precision, limit of quantification, limit of detection, robustness, ruggedness, solution stability and recovery. Relative standard deviation associated with all the parameters was less than 2%, showing compliance with the acceptance criteria of ICH guidelines.