Asian Journal of Pharmaceutical Research

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A New High-Performance Liquid Chromatographic Method for Identification and Quantification of Fosinopril Sodium and its Related Impurities in Bulk Drug Product


Affiliations
1 Department of Organic Chemistry, Gayathri PG College, Vizianagaram, Andhra Pradesh, India
2 Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
3 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 Fosinopril Sodium and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 3.0 μm make: Hypersil ODS column employing HPLC Water: Acetonitrile:1% orthophosphoric acid in water in the ratio of 65:25:10 (v/v/v) as mobile phase initially with gradient run and flow rate set as 1.2 mL/min was chosen. Time/A/B: Time/A/B/C: 30/50/40/10; 35/50/40/10; 45/35/55/10; 80/35/55/10; 90/65/25/10; 100/65/25/10. All impurities were eluted within 60 minutes. The column temperature was maintained at 35°C and a detector wavelength of 210 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, Fosinopril Sodium, LOQ, LOD.
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  • A New High-Performance Liquid Chromatographic Method for Identification and Quantification of Fosinopril Sodium and its Related Impurities in Bulk Drug Product

Abstract Views: 395  |  PDF Views: 5

Authors

Botsa Parvatamma
Department of Organic Chemistry, Gayathri PG College, Vizianagaram, Andhra Pradesh, India
Tentu Nageswara Rao
Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India
T. B. Patrudu
Department of Chemistry, Gitam University, Hyderabad Campus, Telangana, India
Karri Apparao
Department of Organic Chemistry, Gayathri PG College, Vizianagaram, Andhra Pradesh, India

Abstract


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of Fosinopril Sodium and its related impurities. The chromatographic separations were achieved on (250×4.6 mm), 3.0 μm make: Hypersil ODS column employing HPLC Water: Acetonitrile:1% orthophosphoric acid in water in the ratio of 65:25:10 (v/v/v) as mobile phase initially with gradient run and flow rate set as 1.2 mL/min was chosen. Time/A/B: Time/A/B/C: 30/50/40/10; 35/50/40/10; 45/35/55/10; 80/35/55/10; 90/65/25/10; 100/65/25/10. All impurities were eluted within 60 minutes. The column temperature was maintained at 35°C and a detector wavelength of 210 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, Fosinopril Sodium, LOQ, LOD.