Development and validation of stability indicating RP-HPLC method for the estimation of azilsartan in Bulk

K. Mounika; M. P. Nageswarrao; Y. Siva Kumari; G. N. L. Priyanka; P. Susmitha; P. Susmitha; R. Sadhakvally

doi:10.53730/ijhs.v6nS5.10435

Authors

K. Mounika
kalukurimounika@gmail.com
Department of Pharmaceutical Analysis, AM Reddy Memorial college of Pharmacy, Petlurivaripalem, Nararaopet, Guntur, Andhra Pradesh, India
M. P. Nageswarrao Andhra University college of Pharmacy, Visakhapatnam, India
Y. Siva Kumari Andhra University college of Pharmacy, Visakhapatnam, India
G.N.L.Priyanka Department of Pharmaceutical Analysis, AM Reddy Memorial college of Pharmacy, Petlurivaripalem, Nararaopet, Guntur, Andhra Pradesh, India
P. Susmitha Department of Pharmaceutical Analysis, AM Reddy Memorial college of Pharmacy, Petlurivaripalem, Nararaopet, Guntur, Andhra Pradesh, India
P. Susmitha Department of Pharmaceutical Analysis, AM Reddy Memorial college of Pharmacy, Petlurivaripalem, Nararaopet, Guntur, Andhra Pradesh, India
R. Sadhakvally Department of Pharmaceutical Analysis, AM Reddy Memorial college of Pharmacy, Petlurivaripalem, Nararaopet, Guntur, Andhra Pradesh, India

Keywords:

Azilsartan, RP-HPLC, Validation, development

Abstract

Angiotensin-receptor blockers are often considered adequately efficacious in reducing blood pressure. By accepting the current regulatory requirements for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of Azilsartan has been developed. The optimized method was achieved using unisol C-18 (3μm, 4.6×150mm) coloumn with mobile phase consisting of mixture acetonitrile and methonal (90:10v/v) with a flow rate of 0.8ml/min at 249nm. The Linear concentration range is 2-10μg/ml. The detection and quantitation limit was found to be 0.45μg/ml. And the detection limit was found to be 0.149μg/ml. There are no interfering peaks under performed degradation conditions. The optimized method was validated according to ICH guidelines.

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