. 2019; 16(4): 457-465

A rapid stability indicating HPLC method for the analysis of Leflunomide and its related impurities in bulk drug and formulations

Useni Reddy Mallu, Venkateswara Rao Anna, Bikshal Babu Kasimala
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Guntur, Andhra Pradesh - 522502, India

INTRODUCTION: Leflunomide (LFNM) is a drug belongs to isoxazole derivative and having immunosuppressive and anti-inflammatory activities. Literature search confirms that there is no method reported for the simultaneous estimation of LFNM and its related impurities A and B in pharmaceutical dosage forms and in bulk drug. Hence the present work aimed to develop a simple stability indicating RP-HPLC method for the separation and quantification of LFNM and its impurities A and B.
METHODS: Systematic trails of method condition like mobile phase ratio, pH, flow rate, stationary phase and detector wavelength was performed for the simultaneous analysis of LFNM and its related impurities A and B. The developed method was validated as per the ICH guidelines including forced degradation studies
RESULTS: Optimized separation was achieved on Thermo Scientific Hypersil ODS C18 column (250mm×4.6mm; 5µ id) using mobile phase composition of acetonitrile, methanol and 0.1M sodium perchlorate in the ratio of 40: 30: 30 (v/v); pH 4.6, at a flow rate of 1.0mL/min in isocratic elution. UV detection was carried at wavelength of 246nm. Well resolved peaks were observed with high number of theoretical plates, less tailing factor and reproducible relative retention time and response factor. The method was validated and all the validation parameters were found to be within the acceptance limit. Stability tests were done through exposure of the analyte solution to five different stress conditions i.e 1 N HCl, 1 N NaOH, 3% H2O2, thermal degradation of powder and exposure to UV radiation. The method can successfully separate the degradation products along with both the impurities studied. The % degradation was also found to be less.
DISCUSSION AND CONCLUSION: The method developed for LFNM is simple, precise and can applicable for the separation and quantification of LFNM and its related impurities in bulk drug and pharmaceutical formulations.

Keywords: Leflunomide, impurity A, impurity B, stress degradation, HPLC.


Useni Reddy Mallu, Venkateswara Rao Anna, Bikshal Babu Kasimala. A rapid stability indicating HPLC method for the analysis of Leflunomide and its related impurities in bulk drug and formulations. . 2019; 16(4): 457-465

Corresponding Author: Bikshal Babu Kasimala, India


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