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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 6
First page : ( 2393) Last page : ( 2397)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00442.0

Development and validation of method for the estimation of aprepitant Form-II in aprepitant drug substance (Mixture of aprepitant Form-I and Form-II) by powder X-Ray diffractometer (PXRD)

Sadul Sudhir K, Mr. Gavaskar D., Mrs. Kalaivani R.A.*

Department of Chemistry, Vels university, Pallavaram, Chennai-600043, Tamil Nadu, India

*Corresponding Author E-mail: dramadan@scs-net.org, mandil@scs-net.org

Online published on 24 August, 2018.

Abstract

A PXRD quantitative method is developed and validated for the estimation of Aprepitant Form-II in Aprepitant Drug substance (mixture of Aprepitant Form-I and Form-II). The PXRD conditions for the Slow scan method developed for the estimation of Aprepitant Form-II at 12.6 with a radiation source of Copper Kα1 (λ = 1.54060A°). The Angular range was 11.0 to 13.0°2θ with the Voltage and Current set to 40KV and 40mA and a step size of 0.005° along with sample rotation of 30 rpm. The scan type is Locked coupled, continuous with a high sensitive Lynxeye detector. The developed method was validated for Specificity, Linearity, Precision, accuracy and Robustness. The PXRD method is Linear with a concentration range of 5% to 90% w/w. with correlation coefficient of 0.999. The recoveries ranged between 89.6%-103.4% for 10% and 60% levels. The Method was found to be specific, linear, sensitive, precise, accurate and robust for the estimation of Aprepitant Form-II in Aprepitant Drug substance.

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Keywords

Power X-ray Diffactometer, Aprepitant Form-II, Aprepitant Drug Substance.

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