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Stability indicating RP-HPLC Method Development and Validation of Doxofylline

R. Kumanan, R. Manasa and M. Jitendra Reddy

A simple, selective, rapid, specific and stability indicating reversed phase high performance liquid chromatography (RP-HPLC) method for the determination of doxofylline in the pharmaceutical dosage form has been developed and validated. The separation and quantification were achieved on a Supelco C18 DB (150 × 4.6 mm) column using a mobile phase of water : methanol : acetonitrile (75 : 20 : 5 v/v), at a flow rate of 1 mL/min with detection of analyte at 278 nm. The method was validated according to the regulatory guidelines with respect to precision, accuracy, linearity, specificity and robustness. All the validation parameters were within acceptance range.