Stability - Indicating Lc Method for the Simultaneous Determination of Telmisartan and Hydrochlorothiazide in Dosage Form

Patil, Kiran R.; Shinde, Devanand B.

doi:10.4067/s0717-97072012000100014

Cited by 4 publications

(3 citation statements)

References 8 publications

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“…The drug undergoes degradation under acidic, basic, peroxide, and thermal degradation conditions. Patil and Shinde [84] developed a simple, rapid, precise, and stability-indicating method for the quantitative simultaneous estimation of telmisartan and hydrochlorothiazide in combined pharmaceutical dosage form. Telmisartan, hydrochlorothiazide, and their combination drug products stressed samples were analyzed by this method.…”

Section: Stabilitymentioning

confidence: 99%

Telmisartan

Bakheit

Abdelgalil

Mustafa

et al. 2015

Profiles of Drug Substances, Excipients and Related Methodology

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Section: Stabilitymentioning

confidence: 99%

Telmisartan

Bakheit

Abdelgalil

Mustafa

et al. 2015

Profiles of Drug Substances, Excipients and Related Methodology

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“…Benidipine alone, and in combination with other drugs, were estimated by UV-Vis spectrophotometric methods [ 12 , 13 , 14 , 15 ], derivative spectroscopic method [ 16 ], spectrofluorometric method [ 17 ], HPLC [ 18 , 19 ], and LC-MS/MS [ 20 , 21 ]. Analysis of telmisartan using spectrophotometric [ 22 , 23 ], HPLC [ 24 , 25 , 26 , 27 , 28 ], HPTLC [ 28 ], LC-MS/MS [ 29 , 30 ], and capillary electrophoresis [ 31 ] was reported in the literature. Many HPLC procedures are depicted for the assay of benidipine and telmisartan in pharmaceutical preparation [ 32 , 33 ].…”

Section: Introductionmentioning

confidence: 99%

Sensitivity Enhanced Ecofriendly UV Spectrophotometric Methods for Quality Control of Telmisartan and Benidipine Formulations: Comparison of Whiteness and Greenness with HPLC Methods

Chohan

Attimarad

Venugopala

et al. 2022

IJERPH

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The development of an environmentally friendly analytical technique for simultaneous measurement of medicines with large concentration differences is difficult yet critical for environmental protection. Hence, in this work, new manipulated UV-spectroscopic methods with high scaling factors were established for concurrent quantification of telmisartan (TEL) and benidipine (BEN) in fixed-dose combinations. Two different methods were developed and established by calculation of peak height at zero crossing point of second derivative and the ratio of first derivative spectra with a scaling factor of 200 and 100, respectively. The absorption difference between the peaks and troughs of the ratio spectra, as well as continuous subtraction from ratio spectra, were established as additional methods. In addition, new procedures were validated using ICH recommendations. The proposed methods’ linearity curves were constructed in the range of 0.5–10 µg mL−1 and 1–30 µg mL−1 for BEN and TEL, respectively, under optimized conditions. Furthermore, both the detection (0.088–0.139 µg mL−1 for BEN and 0.256–0.288 µg mL−1 for TEL) and quantification limits (0.293–0.465 µg mL−1 for BEN and 0.801–0.962 µg mL−1 for TEL) were adequate for quantifying both analytes in the formulation ratios. The accuracy and precision were confirmed by the good recovery percent (98.37%–100.6%), with low percent relative error (0.67%–1.70%) and less than 2 percent relative standard deviation, respectively. The specificity of the methods was proven by accurate and precise outcomes from the standard addition method and analysis of laboratory mixed solutions with large differences in concentrations of both analytes. Finally, the BEN and TEL content of the formulations was determined simultaneously without prior separation using these first ever reported spectroscopic methods. Furthermore, developed UV derivative spectroscopic methods demonstrated high greenness and whiteness when compared to the reported HPLC methods. These findings show that the projected methods were effective, practical, and environmentally acceptable for quality control of BEN and TEL in multicomponent formulations.

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“…the risk of cardiovascular disease [4][5][6] . Recently, these two drugs have been developed into a fixed-dose combination (FDC) drug.…”

mentioning

confidence: 99%

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

Choi¹,

Park²,

Kim³

2021

ijps

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Choi et al.: Estimation of Rosuvastatin Calcium and Telmisartan in Fixed-Dose Complex Dual-Layer Tablets in Six Dosage FormsFixed 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.

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Stability - Indicating Lc Method for the Simultaneous Determination of Telmisartan and Hydrochlorothiazide in Dosage Form

Cited by 4 publications

References 8 publications

Telmisartan

Telmisartan

Sensitivity Enhanced Ecofriendly UV Spectrophotometric Methods for Quality Control of Telmisartan and Benidipine Formulations: Comparison of Whiteness and Greenness with HPLC Methods

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

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