Development of rapid, simple and novel method for the validation of Abaloparatide and Teriparatide in Combined Dosage Form By RP-HPLC Method

Abaloparatide and teriparatide are prescription, self-injected, osteoanabolic (bone-building) drugs used to treat high-risk osteoporosis by strengthening bone mineral density and reducing fractures. The main aim of the present study was to develop a method to determine a Simple, Rapid, Selective, Precise, Accurate and reproducible RP-HPLC method for Simultaneous estimation of Abaloparatide and Teriparatide in bulk and pharmaceutical formulations as per ICH guidelines. The separation of the drug was achieved on Phenomenex Luna C18 (4.6×250mm, 5μm) column. The mobile phase was Acetonitrile: Phosphate Buffer (pH-4.6) in the ratio of 45:55v/v at a flow rate of 1.0mL/min elutes was monitored at 245nm, with a retention time of 2.102 and 3.537 minutes for Abaloparatide and Teriparatide respectively. The method was validated and the response was found to be linear in the drug concentration range of 6μg/mL-14μg/mL for Abaloparatide and 18μg/ml to 42μg/mL for Teriparatide and values of the slope and the correlation coefficient were found to be 77824 and 0.999 for Abaloparatide and 10515 and 0.999 for Teriparatide respectively. The LOD and LOQ values of Abaloparatide and Teriparatide were found to be 0.6μg/mL and1.8μg/mL and 0.8μg/mL and 2.4μg/mL respectively. The method was also employed on formulation and the recovery of Abaloparatide and Teriparatide were found to be 100.351 and 100.93 respectively.