Volume No. :   7

Issue No. :  3

Year :  2017

ISSN Print :  2231-5705

ISSN Online :  2231-5713


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



Address:   Tentu Nageswara Rao1*, A. Vijayalakshmi2, Karri Apparao1, N. Krishnarao1
1Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India.
2Department of Marine Living Resources, Andhra University, Visakhapatnam, Andhra Pradesh, India.
*Corresponding Author
DOI No: 10.5958/2231-5713.2017.00024.1

ABSTRACT:
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 30oC 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.
KEYWORDS:
HPLC, Method validation, related impurities, Olmesartan Medoxomil, LOQ, LOD.
Cite:
Tentu Nageswara Rao, A. Vijayalakshmi, Karri Apparao, N. Krishnarao. A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its related impurities in bulk drug product by HPLC. Asian J. Pharm. Tech. 2017; 7 (3): 147-152.
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