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Stability indicating reverse phaseHPLC analyticalmethod development and validation for quantitative determination of orlistat in canola oil

Pallavi Gupta, Loveraj Singh, Kamal Kishor, Dhananjay Dwivedi, Kona.S.Srinivas

A rapid, linear, sensitive and specific reverse phase HPLC method was developed and validated to quantify Orlistat in canola oil. Method was developed by using different solvents of different ratios with temperature to enhance the miscibility of oil and solubility of drug. Complete extraction of drug from oil is achieved and can be detected with the analytical run time of approximately 12min. The method has been found to be linear and shows stability of orlistat. A method with isocratic separation was achieved using a C-18, 150mm4.6mmi.d.,5mparticle size columnwith a flow rate of 2.0mL/min with a UV detector to monitor the elute at 210nm. The mobile phase consisted of buffer (0.1% ortho phosphoric acid): acetonitrile.