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Research Journal of Science and Technology
Year : 2018, Volume : 10, Issue : 2
First page : ( 98) Last page : ( 104)
Print ISSN : 0975-4393. Online ISSN : 2349-2988.
Article DOI : 10.5958/2349-2988.2018.00014.1

A New Analytical Method Validation and Quantification of Residual Solvents in Telmisartan Bulk Drug Product by Headspace gas Chromatographic Method

Rao Tentu Nageswara1,*, Patrudu T.B.2, Kumar A Suneel.3, Rao N. Krishna1, Apparao Karri1

1Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India

2Department of Chemistry, GITAM University, Hyderabad, Telangana, India

3Department of Biochemistry, Acharya Nagarjuna University, Andhra Pradesh, India

*Corresponding Author E-mail: tnraochemistry@gmail.com

Online published on 7 July, 2018.

Abstract

A simple and inexpensive method was developed with gas chromatographic method with FID detection for determination of telmisartan residual solvents (methanol, 1-Butanol, tetrahydrofuran and toluene). The chromatographic separations were achieved on J&W B-624 30m, 0.53mm, film thickness 3.0 μm column, helium as carrier gas with flow rate 4.2 mL/min, Injector Temperature is 220°C, detector temperature is 250°C, Head Space Bath Temperature is 90°C, transfer line temperature is 210°C were chosen. Three residual solvents were eluted within 20 minutes. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, limit of detection and Limit of quantification.

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Keywords

GC, FID, Method validation, residual solvents, telmisartan.

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