alexa Abstract | Development and Validation of Stability Indicating RP-HPLC Method for Determination of Related Substances in Fenoprofen Calcium

Journal of Chemical and Pharmaceutical Research
Open Access

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Abstract

New Reverse Phase-Liquid Chromatography (RP-HPLC) method has been developed for simultaneous determination of Fenoprofen Calcium and its related process impurities. Chromatographic separation was achieved on C8 column (Size: 250 x 4.6 mm; 5 μm particle size) at flow rate 1.5 mL/min. with 270 nm detection through gradient elution. Mobile phase-A (MP-A) consists of Water : Acetic acid (980:20) and Mobile phase-B (MP-B) consists of Acetonitrile : Acetic acid (980:20). Product was subject to stress conditions like acid, base, oxidative, thermal, photolytic and humidity degradation. No degradation was observed in acidic, basic, photolytic, thermal and humidity medium. Degradation was observed in Oxidative medium. However, no interference observed due to degradation impurities and Fenoprofen Calcium and its related process impurities. As part of the method validation, specificity, LOD, LOQ, linearity, accuracy, precision, robustness and ruggedness were determined. LOD values were achieved between 0.002% and 0.01%. LOQ values were achieved between 0.01% and 0.03%. Good linearity (r2 > 0.99) was obtained ranging from LOQ to 150%. Recovery was verified for all impurities at concentrations ranging from LOQ to 150%. Hence newly developed RP-HPLC method was capable for well separation of all analytes with acceptable resolution and tailing factor.

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Author(s): Dasari Purnachand Arava Veerareddy Bhoomireddy Ramadevi and Bethi Madhusudhanreddy

Keywords

Development & Validation, Liquid Chromatography, Impurity Profile, Degradation Studies, Fenoprofen Calcium, RP-HPLC Method

 
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