Development, Validation of RP-HPLC Method and GC MS Analysis of Desloratadine HCL and IT"s Degradation Products

Abstract

Introduction: Efficacy and safety of drug therapy is directly related to the stability of active pharmaceutical ingredient (API) and drug product used. Forced degradation studies (also called stress testing) are performed for better understanding of API and drug product stability. Thus, stress testing is a prognostic research tool used to ascertain stability of drug molecules and provide support for developing a stability-indicating method. Aim: The research aim is Development, Validation of RP-HPLC Method and GC MS Analysis of Desloratadine HCL and Its Degradation Products. Objective: The objective of the current study was to develop a validated specific stability-indicating reversed-phase liquid chromatographic method for the quantitative determination of Desloratadine HCl in bulk samples in the presence of degradation products. Method: Desloratadine HCL was subjected to variable pH, oxidative, dry heat and photolytic stress condition as per ICH guideline for the stability study. Stressed samples were further studied by the validated RP-HPLC method and also studied by GC-MS to characterize degradation products (Fig 15). Result: At oxidative stress, degradation products were generated and detected by GCMS. Slight degradation was observed in acidic and alkaline stress while no degradation was observed in other stress conditions. Separation of degradation products from pure drug was achieved on C18 column 5µ (4.6 X 250 mm) using the mobile phase consists a mixture of Orthophosphoric acid (0.1%V/V), Acetonitrile and Methanol (50:35:15 V/V/V). The detection was carried out at 242 nm. The proposed validated LC method was used to quantify the stressed test solutions in order to ascertain stability-indicating potential of the method. Conclusion: The established LC approach has been shown to be suitable for determining the quality of Desloratadine HCl from its dosage form and assessing its stability when required.