Asian Journal of Pharmacy and Technology

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A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its Related Impurities in Bulk Drug Product by HPLC.


Affiliations
1 Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
2 Department of Marine Living Resources, Andhra University, Visakhapatnam, Andhra Pradesh, India
     

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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.
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  • A New Analytical Method Validation and Quantification of Olmesartan Medoxomil and its Related Impurities in Bulk Drug Product by HPLC.

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Authors

Tentu Nageswara Rao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
A. Vijayalakshmi
Department of Marine Living Resources, Andhra University, Visakhapatnam, Andhra Pradesh, India
Karri Apparao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
N. Krishnarao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India

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.

References