Volume No. :   7

Issue No. :  3

Year :  2017

ISSN Print :  2231-5683

ISSN Online :  2231-5691


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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



Address:   Botsa Parvatamma1, Tentu Nageswara Rao2*, T.B. Patrudu3 and Karri Apparao1
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
DOI No: 10.5958/2231-5691.2017.00025.9

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 35oC 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.
Cite:
Botsa Parvatamma, Tentu Nageswara Rao, T.B. Patrudu, Karri Apparao. A New High-Performance Liquid Chromatographic Method for Identification and Quantification of Fosinopril Sodium and its related Impurities in Bulk Drug Product. Asian J. Pharm. Res. 2017; 7(3): 165-170.
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