Tuesday , 5 March 2024

Method Development and Validtion of Melphalan Injection by RP-HPLC Method

Gummi Vishwanth*, P. Sunith, Naga Jyothi. C
Pharmaceutical Analysis and Quality Control,   JNTUH, Hyderabad, India

A B S T R A C T
A simple, rapid, sensitive, accurate and precise RP-HPLC method has been developed and validated for the estimation of melphalan in injection dosage form. The mobile phase used was a combination of Methanol, Acetonitrile, TEA in the ratio of 55:10:35 respectively. Retention time was found to be 3.99mins. The developed method was validated as per ICH Guidelines. The % purity of Melphalan was found to be 99.11% and Linearity was observed in the range of 60-140 µg /ml with correlation co-efficient of 0.998%. Validation results serve as an authentic proof that the developed method is Reliable. Thus, this method can be preferred for the routine analysis of melphalan in injection dosage forms.
Keywords: Melphalan, RP-HPLC and TEA i

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