Volume No. :   10

Issue No. :  2

Year :  2018

ISSN Print :  0975-4393

ISSN Online :  2349-2988


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



Address:   Tentu NageswaraRao1*, T.B. Patrudu2, Suneel Kumar. A3, N. Krishna Rao1, Karri Apparao1
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
DOI No: 10.5958/2349-2988.2018.00014.1

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 220oC, 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.
KEYWORDS:
GC, FID, Method validation, residual solvents, telmisartan.
Cite:
Tentu NageswaraRao, T.B. Patrudu, Suneel Kumar. A, N. Krishna Rao, Karri Apparao. A New Analytical Method Validation and Quantification of Residual Solvents in Telmisartan Bulk Drug Product by Headspace gas Chromatographic Method. Research J. Science and Tech. 2018; 10(2):98-104.
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