A validated RP-HPLC method for simultaneous estimation of benidipine and telmisartan in bulk and tablet dosage form Shikha Divya1,2, Bhatia Rohit1,* 1Department of Pharmaceutical Analysis, ISF College of Pharmacy, Moga-142001, Punjab, India 2Department of Pharmacy, Usha Martin University, Angara, Ranchi - 835103, Jharkhand *Corresponding Author E-mail: bhatiarohit5678@gmail.com
Online Published on 23 January, 2024. Abstract Background In this work, a novel, simple and accurate reverse phase high-performance liquid chromatographic method with UV detection is presented for the simultaneous estimation of Benidipineand Telmisartan in API and marketed formulations. Objective To develop and validate this method in accordance to regulatory guidelines i.e. ICH Q2B-R1 for analytical parameters. Methods In RP-HPLC the separation was achieved using a Xbridge C18 (250× 4.6 i.d; 5μm) column with isocratic elution using a mobile phase consisting of methanol: acetonitrile (80:20v/v/ with 0.1% v/v TEA) adjusted to pH 5.2 with glacial acetic acid at 1mL/min flow for 10min. Benidipine and Telmisartan, were detected at dual wavelength at 237 and 297nm with retention time (Rt) 6.891 and 8.997 minutes respectively. Results Our new methods (RP-HPLC) were found to (r2>0.999) for both Benidipine and Telmisartan. The developed methods are highly selective, precise and reproducible with %RSD < 2%, Moreover the methods are accurate with recovery more than 99% in both methods. Conclusion The RP-HPLC method results are efficient, simple and easy. These highly sensitive methods were successfully applied for assay determination of both Benidipine and Telmisartan at fixed dose combination. Top Keywords Benidipine, Telmisartan, RP-HPLC, Analytical Validation, ICH Q2B_R1. Top |