Development of Method and Validation for Related Substances in Pemetrexed Injection formulation With HPLC

Development of Method and Validation for Related Substances in Pemetrexed Injection formulation With HPLC

Korupolu Nagu¹, B.S.A. Andrews*, V D N Kumar Abbaraju², Kancharla Vijayalakshmi³, G T Jyotesh Kumar⁴

*^,1,3,4Department of Chemistry, GIS, GITAM University, Visakhapatnam – INDIA – AP – 530045.

²Department of Environmental Sciences, GIS, GITAM University, Visakhapatnam – INDIA – AP – 530045

Abstract

A validated HPLC method was developed for the determination of Pemetrexed (PMD)  in pharmaceutical formulation. Isocratic elution at a flow rate of 1.00ml/min is employed on waters X bridge C18 50 mm × 4.6mm, 3.5µ Column, or equivalent. As a mobile phase 90 volumes of buffer solution and 10 volumes of Acetonitrile. Acetonitrile is utilized as mobile phase B.  UV detection wavelength is set at 230nm.  Injected sample is 5.0μl.   Run time is 16 minutes to Sample, Blank, Placebo, System suitability along with 60minutes to diluted Regular. Approximate retention time is identified to PMD is ± 2.4 minutes. % R.S.D PMD is identified. Mean Percentage recovery to PMD is identified that within specification limit. This work is validated by using rules and regulations given by ICH. Therefore, proposed HPLC process should successfully applied to routine quality control analysis formulations. This process developed is simple also is better to that of different processes those are reported in earlier literature. Values permits application for proposed stability indicating HPLC methodology in syrup dose forms.

Keywords: RP-HPLC Refractive index detector, PMD, flow rate, column, ICH Guidelines, USP reference.