Abstract

MODIFICATION AND VALIDATION OF CLORSULON AND IVERMECTIN ANALYTICAL METHOD BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Elham A. Mobarez*, Hanan A. Azoz, Ashraf Sh. Darwish, Abd- Elazim M. El-Barawy

ABSTRACT

The purpose of analytical measurements is to obtain reliable, precise, consistent and accurate datum. A simple, precise and stability-indicating HPLC method was developed and validated for the simultaneous determination of clorsulon (CLO) and ivermectin (IVR) in pharmaceutical dosage form. The method involves the use of easily available inexpensive laboratory reagents. Validation of a developed analytical method plays a major role in achieving this goal. The two compounds were separated on C18 column [4.6x250mm, particle size 5μm], at the UV detection of 225nm. Isocratic elution of methanol (MOH) and water was used as a mobile phase with various ratios and flow rates, eventually 97: 3 v/v MOH and water was being set with the flow rate of 1mL/min. Effective separation and quantification was achieved in less than 10 min. The correlation coefficient (r2) for CLO and IVR were found 0.999 and 0.998 respectively. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, further the limit of detection and limit of quantification of clorsulon and ivermectin concentrations were found to be 0.025 and 0.075μg/mL and 0.01and 0.03μg/mL respectively. Recovery and assay studies of CLO and IVR were within 100.92 to 100.02% indicating that the proposed method can be adoptable for quality control simultaneous analysis of CLO and IVR.

Keywords: Ivermectin, clorsulon and validation parameters