Asian Journal of Pharmaceutical Analysis

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A New Analytical method Validation and Quantification of Entacapone and its Related Substance in bulk Drug Product by HPLC


Affiliations
1 Department of Chemistry, Krishna University, Machilipatnam, A.P., India
2 Department of Chemistry, GITAM University, Hyderabad Campus, Telangana, India
     

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A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of entacapone and its related impurities are (N, N diethyl cyano acetamide), (3,4 Dihydroxy 5-Nitro benzaldehyde) and (2-Z)-2-Cyano-3-(3,4-Dihydroxy-5-nitrophenyl)N,N-diethyl-2- propenamide. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Phenomenex Luna column employing Acetonitrile: HPLC Water in the ratio of 50:50 (v/v) as mobile phase with isocratic at flow rate 0.9 mL/min was chosen. Three impurities were eluted within 15 minutes. The column temperature was maintained at 30°C and a detector wavelength of 210 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, limit of detection and Limit of quantification.

Keywords

HPLC, Method Validation, Related Impurities, Entacapone, LOQ, LOD.
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  • A New Analytical method Validation and Quantification of Entacapone and its Related Substance in bulk Drug Product by HPLC

Abstract Views: 482  |  PDF Views: 1

Authors

G. Kumar
Department of Chemistry, Krishna University, Machilipatnam, A.P., India
T. B. Patrudu
Department of Chemistry, GITAM University, Hyderabad Campus, Telangana, India
Tentu Nageswara Rao
Department of Chemistry, Krishna University, Machilipatnam, A.P., India
M. V. Basaveswara Rao
Department of Chemistry, Krishna University, Machilipatnam, A.P., India

Abstract


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of entacapone and its related impurities are (N, N diethyl cyano acetamide), (3,4 Dihydroxy 5-Nitro benzaldehyde) and (2-Z)-2-Cyano-3-(3,4-Dihydroxy-5-nitrophenyl)N,N-diethyl-2- propenamide. The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Phenomenex Luna column employing Acetonitrile: HPLC Water in the ratio of 50:50 (v/v) as mobile phase with isocratic at flow rate 0.9 mL/min was chosen. Three impurities were eluted within 15 minutes. The column temperature was maintained at 30°C and a detector wavelength of 210 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, limit of detection and Limit of quantification.

Keywords


HPLC, Method Validation, Related Impurities, Entacapone, LOQ, LOD.