Development and validation of dissolution test method for determination of cyclobenzaprine hydrochloride from its formulation using HPLC

Abstract

Aim: The aim of present study was to develop and validate a dissolution test method for Cyclobenzaprine HCL in its formulation using RP-HPLC method. Design: Optimization of chromatographic parameters, development of the dissolution test method using RP-HPLC and to validate the developed methods as per ICH guidelines. Materials and Methods: The optimized dissolution parameters includes USP apparatus II at a paddle rotation rate of 50 rpm and 900 ml of 1.2 pH 0.1N HCL buffer at 37?C0.5?C. Under these conditions, the in vitro release profiles of cyclobenzaprine HCL showed good results. The drug release was estimated by RP-HPLC using column Shodex C18-4E (250×4.6mm×5mm), detection wavelength 289.4 nm having the flow rate 1.0 mL/min using Acetonitrile : phosphate buffer (3.0 pH) in the proportion of 65:35%v/v. Results: The percent drug amount released estimated by proposed method was found to be 99.04%, The method was found to be linear with correlation coefficient was found to be 0.9991 in the concentration range was 2-10 mg/mL. The mean % recovery of Cyclobenzaprine was found to be 100.04.Precision values observed less than 2.All the validation parameters were within the acceptance range. Conclusion: The results obtained by proposed dissolution method for tablet formulation containing Cyclobenzaprine HCL are reliable, precise and accurate. Hence it was routinely adopted for dissolution analysis of the said drugs in the formulation. Keywords: Cyclobenzaprine HCL, Dissolution test, RPHPLC, Validation.