Abstract

A selective and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Efavirenz. 10 mg of Efavirenz was dissolved in mobile phase. 25 mg of Efavirenz standard was transferred into 25ml volumetric flask, dissolved in mobile phase & make up the volume with mobile phase. Accurately weighed around 25mg of Efavirenz working standard, taken into a 25ml volumetric flask, then dissolved in mobile phase and diluted to volume with the mobile phase to obtain a solution having a known concentration of about 1000 mcg/ml. To determine the accuracy of the proposed method, recovery studies were carried out by adding different amounts (80%, 100%, and 120%) of pure drug of EFAVIRANZ were taken and added to the pre-analyzed formulation of concentration 10g/ml. From that percentage recovery values were calculated.The precision of each method was ascertained separately from the peak areas & retention times obtained by actual determination of five replicates of a fixed amount of drug. Efavirenz (API). Influence of small changes in chromatographic conditions such as change in flow rate (0.1ml/min), Temperature (20C), Wavelength of detection (2nm) & acetonitrile content in mobile phase (2%) studied to determine the robustness of the method are also in favour of (Table-4, % RSD < 2%) the developed RP-HPLC method for the analysis of Efavirenz. Further dilution was done by transferring 0.1 ml of the above solution into a 10ml volumetric flask and make up the volume with mobile phase.

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