METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF FORMOTEROL FUMARATE IN MARKETED FORMULATION BY USING RP-HPLC
Nisha Manjhi* Narottam Singh, Muraree Lal, Munesh Singh Bhadouria, Avinash K Kondalkar
ABSTRACT
In the present research work, a successful attempt was made for Validated HPLC method development for the estimation of Formoterol fumarate in marketed formulation which was developed by experimentation based on thorough literature survey and ascertained by statistical parameters of sampling. Liquid chromatographic system from waters comprising of manual injector, Waters 515 binary pump for constant flow and constant pressure delivery and U.V. detector connected to data ace software controlling the instrumentation as well as processing Methanol: Acetonitrile in the ratio of 50:50 v/v at a flow rate of 1.0 ml min-1. A thermo C-18 column (4.6 x 250mm, 5? particle size) was used as the stationary phase, 300nm was selected as the detection wavelength for UV-vis. detector. Proposed method was found to be linear in the range of 1-5?g/ml Formoterol fumarate with the correlation coefficient near to one respectively. The validation and the reliability of proposed method were assessed by recovery study. The recovery of added standards (80%, 1000%) was ranging from 99.20±0.230 to 9.77±0.040%, for Formoterol fumarate. The simplicity, rapidity, accurate and reproducibility of the proposed methods completely fulfill the objective of the research work of estimation of the drug in marketed formulation.
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