Development and Validation of Telmisartan in Tablet Dosage Form by RP-HPLC Assay Technology (original) (raw)
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RP-HPLC Determination Of Telmisartan In Tablet Dosage Forms
Indian Journal of Pharmaceutical Sciences, 2005
A simple fast and precise reverse phase high performance liquid chromatographic method was developed for the determination of telmisartan from tablet dosage forms. A hypersil C18 BDS (250 mmx4.6 mm) from Thermo. In isocratic mode, mobile phase acetonitrile: methanoI (60:40) was used. The flow rate was 1.2 ml/min, and eluent monitored at 245 nm.
2011
An accurate and precise HPLC method was developed for the determination of telmisartan. Separation of the drug was achieved on a reverse phase C8 column using a mobile phase consisting of phosphate buffer and acetonitrile in the ratio of 40:60 v/v. The flow rate was 0.9 ml/min and the detection wavelength was 229 nm. The linearity was observed in the range of 20-60 µg/ml with a correlation coefficient of 0.9996. The proposed method was validated for its linearity, accuracy, precision and robustness. This method can be employed for routine quality control analysis of telmisartan in tablet dosage forms.
The aim of present work was to develop a simple and sensitive, HPTLC for the quantitative estimation of Telmisartan in its single component tablet formulations (40 mg). Telmisartan was chromatographed on silica Gel 60 F254 TLC plate using Toluene:Methanol (7:3 v/v/v) as mobile phase. Telmisartan in methanol scanned by Camag TLC scanner 4 with UV visible detector over wavelength range 200 to 400 nm, showed Rf value of 0.46 at wavelength of 299 nm and selected for further studies. The method was validated in terms of linearity (1-3 ng/ml), precision (intra-day variation 1.61, inter-day variation 2.73), accuracy (81.55 to 87.51%) and specificity. The limit of detection and limit of quantification for Telmisartan were found to be 0.25 ng/spot and 0.7 ng/spot, respectively. It can be concluded from the results that the proposed method was accurate, precise and consistent the determination of Telmisartan in Tablet dosage form. This method was validated as per ICH guideline Q2 (R1). Results suggest that this method can be used for routine estimation of Telmisartan in bulk and pharmaceutical dosage forms.
Dhaka University Journal of Pharmaceutical Sciences, 2013
A simple, specific, sensitive and rapid reversed phase high performance liquid chromatographic (HPLC) method has been developed and validated for the determination of telmisartan in small volumes of rat plasma. Biological sample preparation involving simple extraction with organic solvent, followed by dilution with mobile phase was adopted to eliminate any chromatographic solvent effects. The method was proven to be linear over a plasma concentration range of 10 to 1000 ng/mL with a mean correlation coefficient of 0.9942. The limit of detection and the limit of quantification of the newly developed method were determined to be 1 ng/mL and 10 ng/mL, respectively. The method was successfully applied to assess pharmacokinetic parameters of telmisartan in Wister rats following a single oral dose (1.8 mg/kg, b.w.). The developed method was established as a rapid analytical tool in a pharmacokinetic study as it required short retention time, high precision, sensitivity and small volumes o...
Research Journal of Pharmacy and Technology, 2021
The telmisartan was determined in a rat plasma using developed and validated a reversed-phase high performance liquid chromatographic (HPLC). The pre-treatment of the plasma sample involving liquid-liquid extraction using ethanol as the extracting solvent. The HPLC method validation has been shown a linear calibration curve over a plasma concentrations range of 0.7 to 10µg/mL with a correlation coefficient of 0.9979, the limit of detection and the limit of quantification were determined to be 0.025µg/ml and 0.07µg/ml, respectively. The precision and accuracy were in an acceptable limit. The pharmacokinetic parameters of telmisartan were adequately evaluated following a single oral dose (4mg/kg) in Sprague-Dawley rats. The results observed conclude that the developed bioanalytical HPLC method is appropriate and applicable as an analytical tool in the pharmacokinetic study of telmisartan.
The In-vitro studies and evaluation of telmisartan marketed tablets
Journal of Drug Delivery and Therapeutics
Tablets or capsules taken orally remain one of the most effective means of treatment available. The effectiveness of such dosage forms relies on the drug dissolving in the fluids of the gastrointestinal tract prior to absorption into the systemic circulation. The present study reveals the evaluation of four marketed sample of Telmisartan tablets. The main aim of the study is to conduct dissolution test on the tablets to determine the compliance with a given official monograph. Four different marketed samples of Telmisartan were purchased from local market. The Telmisartan tablets were evaluated for the various in-vitro tablet properties such as thickness, hardness, friability, weight variation, drug content, disintegration time and dissolution rate. In-vitro dissolution test is conducted on four different brands of telmisartan tablets to assess their equivalency. All the four marketed samples of Telmisartan have shown good tablet properties and comply with the pharmacopoeial specifi...
International Journal of Applied Pharmaceutics, 2019
Objective: The present study was aimed to develop a rapid, specific and sensitive method based on high performance liquid chromatographic method was developed for the determination of telmisartan using indapamide as an internal standard. Methods: The utilization of single step protein precipitation method using methanol as a precipitating agent becomes suitable for analysis of a large number of samples. The developed method was validated as per US-FDA guidelines for telmisartan in human plasma. Result: An isocratic separation was achieved using Hibar C18 Conclusion: The developed analytical method was found to be rapid, single step, plasma preparation coupled with the simple high-performance liquid chromatography coupled with UV detection (HPLC-UV) isocratic chromatographic apparatus makes the method cost-effective and suitable for analysis of a large number of samples. (250 x 4.6 mm, 5 μm) column using 10 mmol ammonium formate solution (pH 4.0)methanol (70:30, v/v) as the mobile phase. Detection was carried out at 275 nm. The method was validated over the range of 0.1-1.5 µg/ml in human plasma with a regression analysis of 0.996. The percentage recovery of the present method was found to be 94.0-99.2 %.
International Journal of Phytopharmacy, 2012
A simple, sensitive and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method has been developed for the quantitative estimation of Telmisartan (TELM) in the pharmaceutical formulations. Chromatographic separation was achieved on a 250 × 4.6 mm, 5µ, Waters symmetry column. The flow rate was 1 ml/min and eluent was monitored by absorbance at 230 nm using a mixture of Methanol and Acetonitrile (pH 3.0±0.01) in the ratio of 30:70 (v/v). The retention time of Telmisartan was found to be 7.9 min. Calibration plots were linear in the concentration range of 10-50 µg/ml for Telmisartan with correlation coefficient (R 2) 0.999. The proposed method was validated by testing its linearity, recovery, specificity, system suitability, precision (Interday, intraday, analyst and instrument precision), robustness and LOD/LOQ values and it was successfully employed for the determination of Telmisartan in pharmaceutical tablet formulations.
Stability-Indicating RP-HPLC Method for Analysis of Telmisartan in the Dosage Form
International Journal of Pharmaceutical Chemistry, 2012
A simple, precise, sensitive and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for quantitative analysis of Telmisartan (TELM) in pharmaceutical dosage forms. Chromatographic separation of TELM and its degradation products were achieved on a C 18 , 250 × 4.6 mm, 5µ, Waters symmetry column. The flow rate was 1.0 mL/min, the column Temperature 40 0 C, and detection was by absorption at 230.0 nm using a photodiode array detector. The number of theoretical plates and tailing factor for TELM were 8.721 and 1.018, respectively. TELM was exposed to thermal, photolytic, hydrolytic (acidic and alkali), and oxidative stress, and the stressed samples were analyzed by use of the proposed method. Peak homogenecity data for TELM in the chromatograms from the stressed samples, obtained by use of the photodiodearray detector, demonstrated the specificity of the method for analysis of TELM in the presence of the degradation products. The linearity of the method was excellent over the range 10-50 µg/mL. The correlation coefficient was 0.999. Relative standard deviations of peak areas of all measurements were always less than 2%. The proposed method was found to be suitable and accurate for quantitative analysis of TELM and study of its stability.