Sang-Ho Lee, Sang-Ho Lee, Jong-Hyuk Lee and Joo-Eun Kim* Pages 1 - 11 ( 11 )
Background: Telmisartan and rosuvastatin calcium fixed-dose combination double-layer tablet is used for hypertension and hyperlipidemia treatment. Owing to the critical problem in establishing the specificity, precision, and accuracy of the USP analysis method and simultaneous analysis method for both components, an analysis method that could be applied to researchers in the field is urgently needed.
Objective: To develop and validate a reversed phase-high-performance liquid chromatography method for the quantitative analysis of dissolution samples of telmisartan and rosuvastatin calcium fixed-dose combination double-layer tablets, as a hypertension and hyperlipidemia treatment.
Methods: The developed analysis method was validated according to USP Category I requirements. The validity of the quantitative assay of the dissolution test solution was determined based on the system suitability, specificity, linearity, accuracy, precision, and solution stability of the assay for the components.
Results: The developed method was selective and precise. The retention times of telmisartan and rosuvastatin calcium was 8.1 min and 2.8 min, respectively, and system suitability was 0.217 and 0.17, respectively. Both components showed linearity at 10–120% concentration. The accuracy and precision were also within acceptable limits. The drugs in the dissolution samples were stable for a long time, no interaction occurred between the excipients and active pharmaceutical ingredients, and no interference was observed in the analysis.
Conclusion: The quantitative analysis of the double-layered formulation of telmisartan and rosuvastatin calcium was accurate, selective, and precise. Therefore, this method can be recommended for use in the industrial quality control of telmisartan and rosuvastatin calcium formulations.
Telmisartan, rosuvastatin calcium, dissolution, method validation, quantitative analysis method, drug product, high-performance liquid chromatography
Emerging Industry MD group, Korea Evaluation Institute of Industrial Technology, 305 Tehran-ro, Gangnam-gu, Seoul, 06152, Department of Pharmaceutical Engineering, Catholic University of Daegu, Hayang- Ro 13-13, Gyeongsan city, Gyeongbuk 38430, Department of Pharmaceutical Engineering & Big data Engineering, Catholic University of Daegu, Hayang-Ro 13-13, Gyeongbuk 38430, Department of Pharmaceutical Engineering, Catholic University of Daegu, Hayang- Ro 13-13, Gyeongsan city, Gyeongbuk 38430