Development And Validation Of Rp-Hplc Method For Estimation Of Apremilast In Bulk And Pharmaceutical Dosage Form
Keywords:
Reverse Phase High performance liquid chromatography (RP-HPLC), Apremilast, Validation, Mobile phase, Method Development, Orthophosphoric acid, AcetonitrileAbstract
In this study, a straightforward, reliable, precise, and stable RP-HPLC method for estimating Apremilast in the tablet dosage form. Among the method's many benefits are its straightforward and mobile phase, inexpensive solvents, quick analysis. The method uses a Zodiac C18 (150 x 4.6mm) 5µ column with a mobile phase of Water: Acetonitrile: OPA (buffer) in the ratio of (25:75:0.2 v/v) flow rate of 1.0 ml/min Detection at 230 nm, with a sharp peak at 3.60 minutes for Apremilast work. The method exhibits good linearity (r2 = 0.9999) over a concentration range of 2.50-7.50 µg/ml. The % RSD values for method precision and intermediate precision studies were found to be less than 2%. The % recovery was found to be within an acceptable limit 98%-102%.Thus, the created method was described as robust, accurate, exact, and linear. Because the process eliminates the need for costly reagents and also It takes less time and can be used frequently in the business for a standard analysis of the marketed Apremilast tablet dosage form
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