Interprofessional Journal of Health Sciences. Vol.14 No.2 , July - December 2016.

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

Chaowalit Monton, Bawornlak Boonkrungthong, Sukanya Settharaksa, Natawat Chankana, Lukman Sueree, Laksana Charoenchai, and Jirapornchai Suksaeree

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.

Keywords: sodium nitrate, smoking cessation, method validation

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