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Nilesh Jain ¹, Ruchi Jain ¹, Surendra Jain ¹, Deepak Kumar Jain ²

Affiliations
1 Sagar Institute of Research and Technology-Pharmacy, Ayodhya Bypass Road, Bhopal-462036, IN
2 Truba Institute of Pharmacy, Karond Gandhi Nagar Bypass Road Bhopal-462038, IN

Abstract

A novel stability-indicating RP-HPLC method has been developed and validated for quantitative analysis of fenofibrate in the bulk drug and in a pharmaceutical dosage form. Use of a 250 mm×4.6 mm, 5μm particle, C18 column with 95:05%v/v acetonitrile and acetate buffer pH 5.0 as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 268 nm. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. The linearity of the method was satisfactory over the range 10-50 μgmL^-1(correlation coefficient 0.9997). The limits of detection and quantification were 0.011 and 0.043 μgmL^-1, respectively. Recovery of fenofibrate from the pharmaceutical dosage form ranged from 100.6 to 104.1%. Fenofibrate was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the samples were analyzed by this method. The substance was unstable in basic conditions. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of fenofibrate as bulk drug, in respective dosage forms, for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.

Keywords

Fenofibrate, RP-HPLC, Forced Degradation, Method Validation.

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Nilesh Jain ¹, Ruchi Jain ¹, Hemant Swami ², Deepak Kumar Jain ³

Affiliations
1 Shri Ravi Shankar College of Pharmacy, Bhanpura Road, Bhopal, (M.P), IN
2 IPS College of Pharmacy, Gwalior, (M.P), IN
3 Truba Institute of Pharmacy, Karond Bypass, Bhopal, (M.P), IN

Abstract

This work is concerned with application of simple, accurate, precise and highly selective reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of simvastatin and ezetimibe in combined dosage form. Chromatographic separation was achieved isocratically at 25°C±0.5°C on Luna C₁₈ column (250×4.6 mm i.d.) with a mobile phase composed of methanol: water: acetonitrile in the ratio of 75: 18.75: 6.25 % v/v/v at flow rate of 1.8 ml/min. Detection is carried out using a UV-PDA detector at 231 nm. The retention time of simvastatin and ezetimibe was found to be 13.5±0.5 min and 4.02±0.3 min. respectively. The method was found to be linear in the range of 1-50 μg/ml with mean recovery of 99.21% for simvastatin and 99.50% for ezetimibe. The correlation coefficients for all components are close to 1. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method was successfully applied for simultaneous determination of simvastatin and ezetimibe in routine analysis.

Keywords

Simvastatin, Ezetimibe, RP-HPLC.

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