Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR THE DETERMINATION OF ZIPRASIDONE HYDROCHLORIDE IN HUMAN PLASMA

Chitra Bhojan* and Ravi Thengungal Kochupappy

ABSTRACT

The aim of the current study was to develop a simple, sensitive and economic chromatographic method for the quantification of ziprasidone hydrochloride in human plasma by HPTLC method using rosuvastatin as an internal standard. HPTLC separation was achieved on a precoated silica gel 60F254aluminum sheets (20 x10 cm) using the mobile phase toluene: ethanol (8:2 v/v). The densitometric scanning was performed at 318 nm using Camag TLC scanner. The rf values for rosuvastatin and ziprasidone were 0.18 and 0.68 respectively. Protein precipitation technique was employed to extract plasma samples using methanol. Good linearity was obtained between the concentration range of 20 ng/spot to 120 ng/spot of ziprasidone hydrochloride with a correlation coefficient of 0.9580. The LOD and LOQ were found to be 10 ng/spot and 20 ng/spot respectively. The percentage recovery was between 70 to 75 %. Ziprasidone and rosuvastatin were stable in plasma during the study period. The developed method was validated as per the ICH guidelines and proved suitable for determination of ziprasidone hydrochloride in human plasma.

Keywords: Ziprasidone hydrochloride, human plasma, HPTLC, ICH guidelines.