Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE ESTIMATION OF PIPERAQUINE PHOSPHATE IN BULK DRUG AND PHARMACEUTICAL FORMULATION

Vishakha Oimbe*, Shubhangi Raut, Nikita Rahate and Poonam Pardhi

ABSTRACT

The chromatographic method is exploited and validated as per ICH guidelines (Q2R1). The developed method will be applied to the specific estimation of Piperaquine Phosphate in the presence of other components like excipients, degradation impurities, and other sample matrices. The RP-HPLC method is an estimation of Piperaquine Phosphate in bulk and pharmaceutical dosage forms. The proposed RP HPLC method utilizes a Kromasil 100-5 C18 column [(150 x 4.6) mm i.d., 5µm], optimum mobile phase consisted of methanol, Trimethyl amine Buffer in the ratio of 90:10 % v/v), effluent flow rate was kept at 0.8 ml/min and UV detection wavelength 320 nm. In the project RP-HPLC method is developed and validated as per ICHQ2R1guideline the method is found to be accurate and precise over the range of their estimation in standard laboratory solution and sample solution from pharmaceutical formulation.

Keywords: ICH-guidelines, RP-HPLC, Developed Method, Kromasil C18 Column.