CHOI, MIN NYEONG
Development and Validation of a Reversed-phase High Performance Liquid Chromatography Method for the Simultaneous Estimation of Rosuvastatin Calcium and Telmisartan in Fixed-Dose Complex Dual-Layer Tablets in Six Dosage Forms - Vol.83(3), May-June - Mumbai Indian Journal of Pharmaceutical Science 2021 - 451-464p.
Fixed dose complex dual-layer tablets of telmisartan and rosuvastatin calcium have been used for the
treatment of hypertension and hyperlipidemia. However, the current United States Pharmacopoeia analysis
method is limited by the need for twice the time and cost owing to analysis for each active pharmaceutical
ingredient present separately. Due to the critical limitations in establishing simultaneous analysis methods
for both active pharmaceutical ingredients, there is an urgent need for an analysis method that can
be applied for immediate use by researchers. The objective of this study was to develop and validate
a simultaneous quantitative assay using a rapid and selective high performance liquid chromatography
method for the analysis of rosuvastatin calcium and telmisartan in fixed dose combination dual-layer
tablet dosage forms. This method used Kinetex C18 (5 μm, 4.6×150 mm) columns at a flow rate of 1.0 ml/
min and Ultraviolet-visible detector set at a wavelength of 242 nm. The separation was carried out using
an ammonium phosphate monobasic buffer (pH 3.0) and methanol at a ratio of 300:700 as the mobile
phase. The retention times of rosuvastatin calcium and telmisartan were 2.2 and 4.3 min respectively. The
system suitability was 0.41 % for rosuvastatin calcium and 0.63 % for telmisartan, and the peak of each
component showed complete separation from disturbance peaks. The correlation coefficient of the active
pharmaceutical ingredients was approximately 0.999 when the concentration of rosuvastatin calcium was
in the range of 4.44-26.6 μg/ml and the concentration of telmisartan was 0.176-106.6 μg/ml, this indicates
good linearity. The recovery rate relative to the amount added was 97.0–99.6 % for rosuvastatin calcium
and 95.5-102.2 % for telmisartan. Precision and solution stability were within the permissible range.
Validation acceptance criteria were met in all cases. This simultaneous quantitative analysis method was
successfully applied to the quality assessment of six fixed dose combination dual-layer tablets containing
various amounts of rosuvastatin calcium and telmisartan
PHARMACEUTICS
Development and Validation of a Reversed-phase High Performance Liquid Chromatography Method for the Simultaneous Estimation of Rosuvastatin Calcium and Telmisartan in Fixed-Dose Complex Dual-Layer Tablets in Six Dosage Forms - Vol.83(3), May-June - Mumbai Indian Journal of Pharmaceutical Science 2021 - 451-464p.
Fixed dose complex dual-layer tablets of telmisartan and rosuvastatin calcium have been used for the
treatment of hypertension and hyperlipidemia. However, the current United States Pharmacopoeia analysis
method is limited by the need for twice the time and cost owing to analysis for each active pharmaceutical
ingredient present separately. Due to the critical limitations in establishing simultaneous analysis methods
for both active pharmaceutical ingredients, there is an urgent need for an analysis method that can
be applied for immediate use by researchers. The objective of this study was to develop and validate
a simultaneous quantitative assay using a rapid and selective high performance liquid chromatography
method for the analysis of rosuvastatin calcium and telmisartan in fixed dose combination dual-layer
tablet dosage forms. This method used Kinetex C18 (5 μm, 4.6×150 mm) columns at a flow rate of 1.0 ml/
min and Ultraviolet-visible detector set at a wavelength of 242 nm. The separation was carried out using
an ammonium phosphate monobasic buffer (pH 3.0) and methanol at a ratio of 300:700 as the mobile
phase. The retention times of rosuvastatin calcium and telmisartan were 2.2 and 4.3 min respectively. The
system suitability was 0.41 % for rosuvastatin calcium and 0.63 % for telmisartan, and the peak of each
component showed complete separation from disturbance peaks. The correlation coefficient of the active
pharmaceutical ingredients was approximately 0.999 when the concentration of rosuvastatin calcium was
in the range of 4.44-26.6 μg/ml and the concentration of telmisartan was 0.176-106.6 μg/ml, this indicates
good linearity. The recovery rate relative to the amount added was 97.0–99.6 % for rosuvastatin calcium
and 95.5-102.2 % for telmisartan. Precision and solution stability were within the permissible range.
Validation acceptance criteria were met in all cases. This simultaneous quantitative analysis method was
successfully applied to the quality assessment of six fixed dose combination dual-layer tablets containing
various amounts of rosuvastatin calcium and telmisartan
PHARMACEUTICS