METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AZILSARTAN MEDOXOMIL AND CILNIDIPINE IN BULK PRODUCT AND MARKETED FORMULATION BY RP-HPLC Authors: Sawale VS , UMMAMAHESWARI D AND KUMAR M
ABSTRACT
For the simultaneous measurement of Azilsartan Medoxomil (AZIL) and Cilnidipine (CIL) in both bulk
and tablet formulation, a novel, accurate, precise, and robust RP-HPLC technique has been devised,
coupled with sensitive characteristics. The solutes were estimated using an Agilent C18 column with a size
of 100 mm × 4.6 mm, 2.5 ?m. AZIL and CIL were eluted with orthophosphoric acid (0.1 %) buffer:
acetonitrile in a ratio of 82:18 v/v in a 10-minute gradient trial at a flow rate of 1.0 ml/min with an
ambient column temperature of 25°C and monitored at a wavelength of 240 nm. AZIL and CIL were
shown to have retention times of 4.253 min and 6.933 min, respectively. With r2 of 0.999 in both
instances, the Q2A and Q2B validation of the analytical technique showed excellent linearity across the
concentration ranges of 20-100 ?g/mL for AZIL and 5-25 ?g/mL for CIL. The method also displayed
high accuracy values, superb precision (inter-day and intra-day) values, and impressive robustness values.
For regular analysis of the medication combination in bulk and tablet forms, the proposed analytical
technique proved precise, accurate, and robust.
Keywords: Azilsartan Medoxomil, Cilnidipine, RP-HPLC, Simultaneous, Validation, Estimation Publication date: 01/01/2023 https://ijbpas.com/pdf/2023/January/MS_IJBPAS_2023_6720.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2023/12.1.6720