Extrapolation based shelf life establishment of sacubitril and valsartan floating tablet as per ICH Q1e

According to ICH Q1A(R2) of Stability Testing, the purpose of stability testing is to establish a shelf life for drug product and recommended storage conditions. The aim of this research is to evaluate the shelf life of Sacubitril and Valsartan Floating Tablet using extrapolation on basis of data collected from Stability studies and Forced Degradation Studies. The RP-HPLC method to determine the drug content was validated as per guidelines of ICH Q2(R1). The parameter covered for validation were specificity, accuracy, method, precision and intermediate precision, linearity, all parameters achieved the results within predefined acceptance criteria. The Stability studies were performed on accelerated condition at 40°C±2°C/75%±5% and Long Term condition at 25°C±2°C/60%±5% for 6 months. Forced Degradation Studies were performed on Oxidation, Thermal, and Photolytic degradation for 5 days. Extrapolation was performed such that the extended retest period or shelf life was validated using Statistical tools for a future batch formulation for any industry with test results close to the release acceptance criteria. The drug product was unstable in open atmosphere as it failed drug content test with 96.79 % in oxidation degradationon 4^th day. There was no significant changes observed in the stability studies and stability data was evaluated using extrapolation method and statistical tools. Hence, it was proved that the dosage form of Floating Tablet is stable at ambient temperature for estimated 12 months. These studies confirmed that physical and chemical stability of Sacubitril and Valsartan were enhanced in Floating Drug Delivery System. This research study can be fruitful and useful for researchers and pharmaceutical industries to acquire the technique and data of stability of drug product-Floating Tablet of Sacubitril and Valsartan.