DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR QUANTITATIVE ESTIMATION OF VASICINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Abstract

 

 Objective: The aim was to develop and validate a new, rapid, and highly sensitive high performance liquid chromatography (HPLC) method for the quantitative estimation of vasicine in bulk and pharmaceutical dosage form, according to International Conference on Harmonization (ICH) guideline.

Methods: The chromatographic separation was achieved on an agilent 1200 series HPLC system phenyl (250 mm×4.6 mm×5 μm) column packing, using a mobile phase consisting of hexane sulphonic acid-acetonitrile-acetic acid (60:20:1; v/v/v) in isocratic mode. The flow rate was set at 1.0 ml/minute, and ultraviolet detection was monitored at 300 nm.

Results: The method was linear in the concentration range of 3.125-200 ppm/ml with a correlation coefficient of 0.999. The retention time for vasicine was found to be 5.30±0.05 minutes. The main recoveries obtained in the range of 90.476-107.1%, shows that the developed method was accurate and precise (<2% relative standard deviation). The lower limit of detection and limit of quantification were 3.0208 and 9.1541 μg/ml, respectively.

Conclusion: The proposed method met the general requirements with an acceptable performance for validation. This selective method is found to be reliable, accurate, and effectively used for the vasicine. The result showed that the method is achieved a good performance with simple, rapid and accurate characteristics for quantification of vasicine in pharmaceutical preparations. The proposed method can be employed for the routine analysis of the quality of herbal extracts and in formulations.

Keywords: High-performance liquid chromatography, Vasicine, International conference on harmonisation guidelines, Validation, Phenyl column.

INTRODUCTION