Method Validation and Development of RP-HPLC Method of Mebhydroline Napadisylate in Bulk and its Tablet Dosage Form

An accurate, simple, rapid and sensitive HPLC method has been developed for the determination of mebhydroline napadisylate in the tablet. The Chromatography was performed on a reversed phase C-18 column(150 mm × 4.6 mm id, 5μm) by isocratic elution, using a mobile phase of acetonitrile : ammonia 25% (80 : 20 v/v) at ambient temperature 25±5 °C and UV detection operates at 320 nm in an overall analysis time of about 10 min.The total retention time was 1.612 min with a flow rate of 1.0 ml/min. % 0f RSD values for precision is found to be 0.293 (< 2).The limits of detection (LOD) and quantification (LOQ) were 0.03µg/ml and 0.096133µg/ml, respectively. The correlation coefficient for Mebhydroline Napadisylate 0.9972 indicates linearity of the methods within the limits. The linear range of determination for Mebhydroline Napadisylate was 100-500μg/ml. However, the change in flow rate and column temperature also did not show any significant variance. The % recovery was found to be 99.70%-99.41%.  As per ICH guidelines the proposed method is fully validated and found to be linear over a workable drug concentration, accurate, precise and robust.  This HPLC method is selective, precise, and accurate and can be used for routine analysis of pharmaceutical preparation in industrial quality-control laboratories.