Method Development and Validation of Oxybutynin Chloride by RP-HPLC Analytical Technique
A reverse phase high performance liquid chromatography method has been developed and validated for the
determination of oxybutynin chloride on dried bases as per USP method in tablet dosage form. Isocratic elution at a flow rate
of 1.0 ml / min was employed on a symmetry C8 column (75 × 4.6mm, 3.5μm SS) at 45ºC. The mobile phase consisted of
mixture of phosphate buffer and acetonitrle 51:49 (%V/V) and the UV detection wavelength was 210 nm. The Rt value was
found to be 13.71min with a run time of 40 min. The developed method was validated for linearity, accuracy, precision,
detection limit, quantification limit, ruggedness, specificity, system suitability, and solution stability. Results of all validation
parameters were within the limits as per 1CH Guidelines.