METHOD VALIDATION AND QUANTITATION OF SODIUM NITRATE IN 0.5% SODIUM NITRATE MOUTHWASH FOR SMOKING CESSATION

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Published: Oct 5, 2023
Keywords:
sodium nitrate smoking cessation method validation label amount high performance liquid chromatography

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Chaowalit Monton
he Herbal Medicinal Products Research and Development Center (cooperation between Rangsit University, Harbin Institute of Technology, and Heilongjiang University of Chinese Medicine), Faculty of Pharmacy, Rangsit University, Muang, Pathum Thani 12000, Thailand
Bawornlak Boonkrungthong
Department of Pharmacy, Thanyarak Hospital, Thanyaburi, Pathum Thani 12130, Thailand
Sukanya Settharaksa
The Herbal Medicinal Products Research and Development Center (cooperation between Rangsit University, Harbin Institute of Technology, and Heilongjiang University of Chinese Medicine), Faculty of Pharmacy, Rangsit University, Muang, Pathum Thani 12000, Thailand
Natawat Chankana
Sun Herb Thai Chinese Manufacturing, Faculty of Pharmacy, Rangsit University, Muang, Pathum Thani 12000, Thailand
Lukman Sueree
The Herbal Medicinal Products Research and Development Center, Faculty of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand
Laksana Charoenchai
The Herbal Medicinal Products Research and Development Center (Cooperation between Rangsit University, Harbin Institute of Technology and Heilongjiang University of Chinese Medicine), Pathum Thani 12000, THAILAND
Jirapornchai Suksaeree
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Rangsit University, Muang, Pathum Thani 12000, Thailand

Abstract

The aim of this study was to validate and quantify of sodium nitrate in 0.5% sodium nitrate mouthwash for smoking cessation. Analysis method was validated following to ICH Harmonised Tripartite Guideline. Linearity, range, specificity, limit of detection and limit of quantitation, precision, and accuracy were investigated. Results showed a good linearity (R2 = 0.9997). In addition, the method was specific, precise, and accurate. Intraday and interday precision had a coefficient of variation less than 0.3% and 2.5%, respectively. Accuracy represented as recovery was 98.81-102.14%. Limit of detection and limit of quantitation were 0.83 and 2.53 µg/mL, respectively. This method was used to quantitation of sodium nitrate in two formulations of 0.5% sodium nitrate mouthwash produced at Thanyarak Hospital. Formulations without and with preservative were coded as F1 and F2, respectively. Three lots of each formulation were tested. F1 and F2 had percentage label amount in the range of 99.38-102.70%. In conclusion, this analysis method was validated and could be used for quantitation of sodium nitrate in 0.5% sodium nitrate mouthwash for smoking cessation.

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How to Cite
1.
Monton C, Boonkrungthong B, Settharaksa S, Chankana N, Sueree L, Charoenchai L, Suksaeree J. METHOD VALIDATION AND QUANTITATION OF SODIUM NITRATE IN 0.5% SODIUM NITRATE MOUTHWASH FOR SMOKING CESSATION. Interprof J Health Sci [Internet]. 2023 Oct. 5 [cited 2024 Dec. 22];14(2):33-9. Available from: https://li05.tci-thaijo.org/index.php/IJHS/article/view/147
Issue
Vol. 14 No. 2 (2016): July - December
Section
Research Articles
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