HPLC in the present era is an important tool in the separation, identification and quantification of bulk drug and different pharmaceutical formulations. Bepotastine Besilate being a selective histamine H1 antagonist is used in the treatment of allergic rhinitis and chronic utricaria. The present research work emphasizes on the development and validation of an RP-HPLC method with UV detection for the estimation of Bepotastine Besilate in bulk drug and in ophthalmic solution. The separation of the drug is achieved isocratically on a Kromasil C18 column (4.6 mm × 101 mm) with a mobile phase consisting of methanol (60 volumes) and phosphate buffer (40 volumes) with apparent pH of 3.0 (±0.1). The flow rate was maintained constant at 1.0 ml/min. The wavelength of detection was 259 nm. The method is found to be linear (r=0.9904) at a concentration range of 20µg/ml to 100 µg/ml. The intra and inter day precision studies were found to be satisfactory with %RSD not exceeds by 2%. The developed method was found to be accurate. The proposed method is having a thorough output as the analysis involved short run-time i.e. about 4 minutes. The method is meeting with the ICH regulatory requirements as per ICH Q2 (R1) guidelines. Thus the method developed was successfully applied for the estimation of Bepotastine Besilate in bulk and ophthalmic solution as a dosage form with acceptable accuracy and precisions.
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