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A Validated RP-HPLC-UV Method for Identification of Reference Standards of Degradation Products of Fenofibrate

Submitted by webadmin on Wed, 10/19/2016 - 11:51
Pharmaceutical Methods,2014,5,2,79-86.
Published:July 2014
Type:Research Article

A Validated RP-HPLC-UV Method for Identification of Reference Standards of Degradation Products of Fenofibrate

Sugandha Vijay Mulgund1, Sockalingam Anbazhegan2, Bhagyashree Padmakar Pawaskar3 and Satish Yashwant Gabhe4

1Jawaharlal Nehru Technological University and Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Pune, Maharashtra-411041, India.

2Department of Quality Assurance Techniques, Jawaharlal Nehru Technological University, Sinhgad College of Pharmacy, Pune, Maharashtra-411041, India.

3Surya school of Pharmacy, Surya Nagar, GST Road, Vikravandi, Villupuram, T.N-605652, India.

4Center for Advanced Research in Pharmaceutical Sciences, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, Maharashtra-411038, India.


Background: During the stress degradation studies of Fenofibrate the structures of two major degradation products, namely 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl propanoic acid and methyl 2-[4-(4-chlorobenzoyl) phenoxy]-2- methylpropanoate, were characterized using LC-MS/MS studies under alkaline and acidic hydrolytic conditions, respectively. The present communication deals with synthesis, spectral characterization and further application of those reference standards of degradation products in identification of degradation products in bulk sample of drug through retention time matching studies. Methods: The reference standards of the degradation products were synthesized in the laboratory and their identity were confirmed using spectral studies. These were employed for retention matching studies using HPLC studies. The chromatographic conditions were as follows: stationary phase: Waters X Bridge C18 column (250x4.6 mm, internal diameter, particle size 5 μm), mobile phase: acetonitrile: water in 75:25 v/v, column oven temperature: ambient. The chromatograms were monitored at 286 nm with a flowrate of 1 mL/min. The method was validated according to the ICH guidelines. Results: Retention time values of synthesized reference standards were found to be identical with retention time values of those degradation products in stressed samples. The calibration curves showed good linear regression (r2>0.999) within test ranges. The method showed good reproducibility and sensitivity for quantification of both degradation products in samples. Method was precise and %recovery of both reference products was within 98- 102%. Conclusion: This communication emphasizes use of non-compendial reference standards for quantification of degradation products by chromatographic methods. Quantitative validation parameters like Limit of detection and Limit of quantitation were established.

Chemical structures for Fenofibrate and degradation products