Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Atenolol Drug and validation by RP-HPLC Method using ICH Q2 guidelines

Abstract

Now a days, fast dissolving dosage forms are gaining popularity, as this dosage form can be administered without water. Rapid dissolving property, avoiding first pass metabolism and majority of the drug is absorbed through buccal/oral mucosa in to systemic circulation. On oral administration of atenolol undergoes first pass metabolism results in reduced bioavailability up to (60%), so the objective of the present study was to formulate and evaluate fast dissolving oral films of atenolol to overcome the limitation of bioavailability and increase patient’s compliance. In recent studies oral films were prepared by solvent casting method using HPMC K15 as a film formers and PEG 400, glycerin as plasticizers and evaluated for mechanical properties, disintegration and in vitro dissolution. Good mechanical properties and in vitro drug release were shown by all formulations. The Comparing to other formulations, the optimized (F5) Formulation (HPMC K15, CCS and PEG 400) Exhibited drug release of 92.12% in 15 minutes which was significantly high. RP-HPLC is simple, fast, precise, sensitive, and reproducible (liquid chromatography) method was developed and validated for the analysis of atenolol drug formulation. Using C-18 HPLC column separation was carried out. This was maintained at ambient temperature. Analysis was carried out by using UV detector at the wavelength 228 nm. The RP-HPLC method was found to be linear over the concentration ranges from 50-100 μg/mL (r² =0.999). Retention time for atenolol drug formulation was found to be 5.496min. LOQ of method was 5.7308μg/mL and LOD 2.5036μg/mL.

Keywords: Atenolol, Fast dissolving oral film, Bioavailability, Mechanical properties, C18, RP-HPLC, Methanol