Asian Journal of Research in Pharmaceutical Sciences

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A New Simultaneous HPLC Analytical Method for Quantification of Benazepril Hydrochloride and its Related Impurities in Bulk Drug Product


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 benazepril hydrochloride and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Symmetry Shield column employing 0.02M tetrabuthylammonium hydroxide + 0.05 % v/v acetic acid : methanol in the ratio of 50:50 (v/v) as mobile phase with isocratic at flow rate 1.0mL/min was chosen. All impurities were eluted within 30 minutes. The column temperature was maintained at 25°C and a detector wavelength of 240 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.

Keywords

HPLC, Method Validation, Related Impurities, Benazepril Hydrochloride, LOQ, LOD.
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  • A New Simultaneous HPLC Analytical Method for Quantification of Benazepril Hydrochloride and its Related Impurities in Bulk Drug Product

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Authors

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

Abstract


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of benazepril hydrochloride and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Symmetry Shield column employing 0.02M tetrabuthylammonium hydroxide + 0.05 % v/v acetic acid : methanol in the ratio of 50:50 (v/v) as mobile phase with isocratic at flow rate 1.0mL/min was chosen. All impurities were eluted within 30 minutes. The column temperature was maintained at 25°C and a detector wavelength of 240 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Precision, Accuracy, Limit of detection and Limit of quantification.

Keywords


HPLC, Method Validation, Related Impurities, Benazepril Hydrochloride, LOQ, LOD.

References