Analysis Of Olmesartan Medoxomil, Hydrochlorothiazide, And Related Impurities In Pharmaceutical Dosage Forms By Hplc

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Thesis Type: Postgraduate

Institution Of The Thesis: Gazi University, Turkey

Approval Date: 2014

Thesis Language: Turkish

Student: Çağlar SAÇINTI

Supervisor: NİLGÜN GÜNDEN GÖĞER

Open Archive Collection: AVESIS Open Access Collection

Abstract:

In this study, an analytical method for Olmesartan medoxomil, Hydrochlorothiazide, and related impurities in antihypertensive drugs was developed and validated. An Agilent 1100 series HPLC system was used for quantitative analysis. The analytical column used in these experiments was Agilent Zorbax Sb-C18 5 μm 4,6 x 150 mm and its temperature had been kept at 25°C. Gradient elution was performed and the mobile phase consists of 0,020 M NaH2PO4 and acetonitrile. Samples were solved in acetonitrile and 4 μL was found to be the optimum injection volume providing repeatable injections. The elution was monitored at 215 nm by an Agilent UV diyote-array detector. The retention times of Olmesartan medoxomil, Olmesartan impurity A, Olmesartan impurity B, Hydrochlorothiazide, Hydrochlorothiazide impurity A, and Hydrochlorothiazide impurity B were 10,49; 15,87; 21,98; 5,29; 4,87 ve 4,60 respectively. The recovery of Olmesartan medoxomil and Hydrochlorothiazide were 93,3 and 99,0%. The limit of detection (LOD) for Olmesartan medoxomil, Olmesartan impurity A, Olmesartan impurity B, Hydrochlorothiazide, Hydrochlorothiazide impurity A, and Hydrochlorothiazide impurity B were 0,07; 0,10; 0,10; 0,40; 1,40 and 0,76 μg/mL respectively. On the basis of obtained results, it can be said that the analytical HPLC method for Olmesartan medoxomil, Hydrochlorothiazide, and related impurities is fast, selective, accurate, repeatable, and sensitive.