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Asian Journal of Pharmacy and Technology
Year : 2017, Volume : 7, Issue : 3
First page : ( 147) Last page : ( 152)
Print ISSN : 2231-5705. Online ISSN : 2231-5713.
Article DOI : 10.5958/2231-5713.2017.00024.1

A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its related impurities in bulk drug product by HPLC

Rao Tentu Nageswara1,*, Vijayalakshmi A.2, Apparao Karri1, Krishnarao N.1

1Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India.

2Department of Marine Living Resources, Andhra University, Visakhapatnam, Andhra Pradesh, India.

*Corresponding Author E-mail: tnraochemistry@gmail.com

Online published on 17 October, 2017.


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of olmesartan Medoxomil and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Zorbax Eclipse XDB-C8 column employing 00.1% H3PO4 in Water: Acetonitrile in the ratio of 50: 50 (v/v) as mobile phase with gradient initially A: B: 70: 30 and followed as Time/A/B: 25/30/70; 30/30/70; 31/75/25 and runtime is 35 mins at flow rate 1.0 mL/min was chosen. All impurities were eluted within 18 minutes. The column temperature was maintained at 30°C and a detector wavelength of 225 nm was employed. The method was successfully validated by establishing Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.



HPLC, Method validation, related impurities, Olmesartan Medoxomil, LOQ, LOD.


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