Bioanalytical RP-HPLC method development and validation for estimation of azelnidipine and Olmesartan medoxomil in human plasma

Anuja Prabhakar Bhosale, Ashok Pandurang Pingle

Department of Pharmaceutical Chemistry, M G V’s Pharmacy College, Panchavati, Nashik, Maharashtra, India

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Anuja Prabhakar Bhosale, Ashok Pandurang Pingle, 2022. Bioanalytical RP-HPLC method development and validation for estimation of azelnidipine and Olmesartan medoxomil in human plasma. Journal of Medical Pharmaceutical and allied Science V 11 - I 5, Pages - 5232 – 5239. doi: 10.55522/jmpas.V11I5.4270.

ABSTRACT

An accurate, rapid and simple reversed-phase high performance liquid chromatography (RP-HPLC) bioanalytical method was developed for estimation of Azelnidipine (AZP) and Olmesartan medoxomil (OLM)in human plasma. The AZP, OLM and internal standard (IS) were extracted by liquid-liquid extraction technique. Chromatographic separation was accomplished using BDS Hypersil C18, 250 mm X 4.6 mm, 5μ analytical column. The mobile phase consisted of Acetonitrile: Water, pH adjusted with ortho-phosphoric acid in the ratio 60:40 with flow rate of 1ml/min. Detection and quantification were performed by UV detector at 256 nm. The retention times were found to be 10.05±0.02, 4.3±0.02 and 6.9±0.02 for AZP, OLM and IS respectively. The linearity range was found to be 0.5 to 12 μg /ml and 1 to 15 μg /ml for AZP and OLM respectively.The method was validated as per CDER guideline, was found to be suitable for analysis in biological fluid.

Keywords:

Azelnidipine, Olmesartan medoxomil, RP-HPLC, Bioanalytical method, Human plasma.

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