Simaltaneous Determination of Melphalan and Its ProcessRelated Impurities Using a Stability-Indicating and Validated Reverse Phase Hplc Method in a Short Run Time.
Journal Title: IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) - Year 2017, Vol 12, Issue 5
Abstract
Degradation pathway of melphalan was validated by stability indicating reverse phase liquid chromatographic method. melphalan was subjected to stress condition using acid, base or by oxidation, and photolysis. Significant degradation was observed in acid and base stress conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 98.2 %. Efficient chromatographic separation was achieved on a Luna C18 (4.6 x 150 mm) 3 μm stationary phase with simple mobile phase combination. In the developed LC method, the resolution of melphalan and potential impurities such as Dimer impurity, monohydroxy impurity, phthalimide, ethyl ester, elongated melphalan, dihydroxy and monolakylate was found to be more than 2.0. Regression analysis showed correlation coefficient (r) of greater than 0.999 for melphalan and eight potential impurities. This method was capable of detecting the impurities of melphalan at a level of 0.02 % with respect to test concentration of 0.5 mg/mL. The developed rapid LC method was showed specificity, linearity, accuracy, precision and robustness for impurities.
Authors and Affiliations
Jagadeswara Rao K, Murali Mohan SV, *Rama Rao Malla1
Keywords
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- EP ID EP390923
- DOI 10.9790/3008-1205016978
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