Analytical Method Development & Validation For The Simultaneous Determination Of Olmesartan Medoxomil And Azelnidipine In Bulk And It’s Pharmaceutical Formulation By Rp-Hplc
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Abstract
A sensitive high-performance liquid chromatographic (HPLC) method were developed and validated for the estimation of Olmesartan Medoxomil (OLME) & Azelnidipine (AZEL) in bulk and pharmaceutical formulations. The chromatographic separation was achieved by RP- HPLC using a mixture of Acetonitrile: Phosphate Buffer (60:40) pH 4.3 as the mobile phase, a C18 column & at 256 nm with flow rate 1ml/min. The linear and reproducible calibration curve over the range was 2–20 μg/ml for AZEL & 5-50 μg/ml. for OLME. The retention time of OLME & AZEL was found to be 3.122 & 5.342 respectively. These methods were tested and validated for various parameters according to ICH guidelines. The proposed methods were successfully applied for the determination of Olmesartan Medoxomil (OLME) & Azelnidipine (AZEL) in pharmaceutical formulations. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming. The method showed adequate precision with a relative standard deviation (RSD) smaller than 3%. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentration used. The analytical procedure is reliable and offers not only advantages in terms of speed but also met the regulatory requirements for specificity, Linearity, LOD, LOQ, Precision, accuracy