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Asian Journal of Pharmaceutical Research
Year : 2017, Volume : 7, Issue : 3
First page : ( 165) Last page : ( 170)
Print ISSN : 2231-5683. Online ISSN : 2231-5691.
Article DOI : 10.5958/2231-5691.2017.00025.9

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

Parvatamma Botsa1, Rao Tentu Nageswara2,*, Patrudu T.B.3, Apparao Karri1

1Department of Organic Chemistry, Gayathri PG College, Vizianagaram, Andhra Pradesh, India.

2Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India.

3Department of Chemistry, Gitam University, Hyderabad Campus, Telangana, India.

*Corresponding Author E-mail: tnraochemistry@gmail.com.

Online published on 17 October, 2017.

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.

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Keywords

HPLC, Method validation, related impurities, Fosinopril Sodium, LOQ, LOD.

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