Department of Pharmaceutical Analysis, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore- 524346, Andhra Pradesh, India
Medical devices, Regulation, Global harmonization, Healthcare industry, Patient safety ,

A new RP-HPLC method was developed and validated for the simultaneous estimation of Nisoldipine and Telmisartan in pharmaceutical formulations. Using an Inertsil ODS C18 column (4.6×250mm, 5?m) with a mobile phase of acetonitrile (ACN) and potassium dihydrogen phosphate (KH2PO4) (70:30, pH 3), the method achieved effective separation with detection at 225 nm. Retention times were 2.798 minutes for Nisoldipine and 3.587 minutes for Telmisartan. The % purity for Nisoldipine and Telmisartan was 99.87% and 100.27%, respectively. System suitability parameters and resolution were within acceptable limits. Validation according to ICH guidelines demonstrated high linearity (r^2 = 0.999), accuracy (% recovery: 98.56-99.96%), and precision (% RSD: 1.2-1.9%). Low LOD (3.72-0.0242 ?g/mL) and LOQ (7.40-0.0202 ?g/mL) values indicated method sensitivity. This method is suitable for routine analysis of Nisoldipine and Telmisartan, ensuring reliable quantification in pharmaceutical formulations

14 , 1 , 2024