Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF NEOSTIGMINE METHYL SULFATE INJECTION

Nikas Ravindra Ananta*, Prof. T. V. Chorage, Maind Pawan and Pote Vishal

Abstract

The current proposed methodology of the research is to determine the related substances present in Neostigmine by using high-performance liquid chromatographic method. the developed method was validated for their accuracy and reproducibility. Reversed-phase chromatography was performed on Waters 2489 UV 2695 pump, Waters 2998 PDA 2695 pump Software Empower2 photodiode array detector using Ace C18 (250 mm × 4.6 mm, 5 μm particle size) column with pH 6.4 buffer: methanol : acetonitrile in the ratio of 75:10:15 as mobile phase at a flow rate of 1.0 mL/min. by isocratic elution with UV detection at 220 nm. Recovery and Linearity was observed well within the limits (R2 = more than 0.99 for concentration range of LOQ to 150% level for linearity and the % recovery was within the ICH acceptance limits of 85-115%) for all the impurities. The limit of quantitation (LOQ) and limit of detection (LOD) were found to be less than 0.05%. The method was validated as per ICH guidelines. The RSD for intra-day and inter-day (

Keywords: Neostigmine, Estimation of related substances, HPLC.