Estimation Of Irbesartan Research Articles

Development and validatation of HPTLC method for estimation of irbesartan in bulk and tablet dosage form

A simple, rapid and accurate High performance thin layer chromatography is described for the Development and validation of HPTLC method for Irbesartan in bulk and Pharmaceutical dosage form. The separation is carried out on Merck TLC aluminum sheets of silica gel 60 F254 using Ethyl acetate: Chloroform (6.5:3.5v/v) mobile phase. Quantification was done by Densitometric scanning at 254nm. The linearity was found to be the range of 100-500ng/spot for Irbesartan with the correlation coefficient of 0.9992. The regression equation was found to be Y=7.2733x+703.15. The Rf value of Irbesartan was found to be 0.55. The LOD and LOQ were found to 8.24 and 24.74 respectively. Average recovery was found to be 99.66% which show that the method was free from interference from excipients present in the formulation. Simultaneously the Percentage relative standard deviation was well within the range of 2%. The above method was validated according to the ICH guidelines. The established method enabled accurate, precise and applied to the analysis of Irbesartan in bulk and Pharmaceutical dosage form. Â

Method Development and Validation of Irbesartan by RP-HPLC Method

This study includes development of RP-HPLC method for estimation of Irbesartan. The developed method was validated as per ICH guidelines in terms of specificity, accuracy, linearity, LOD, LOQ, ruggedness and robustness. The assay experiment showed that the contents of Irbesartan estimated in the tablet dosage were free from interference of excipients, which indicate that developed method was specific. Recovery of standard added drugs was found to be 97.2–99.9% for Irbesartan indicating that the proposed method was accurate. After performing analysis by different analyst; it was found that the RP-HPLC method for the determination of Irbesartan % RSD of ruggedness for standard 0.0425% and tablet 0.0142% was found to be rugged. % RSD of robustness was well within the limits for standard 0.36% and tablet 1.87% that the proposed method was robust. The LOD was 0.074 μg/ml for standard drug of Irbesartan. For standard drug of Irbesartan the LOQ were found to be 0.24 μg/ml This demonstrated that the developed RP-HPLC method was simple, linear, precise, accurate, robust and rugged, could be conveniently adopted for the routine quality control analysis of Irbesartan from it's pharmaceutical dosage form and bulk drug.

Validated method for estimation of irbesartan in bulk and dosage form by high performance liquid chromatography technique

A simple, specific, accurate and precise new high performance liquid chromatographic method was developed for the estimation of irbesartan in bulk and its developed dosage form. The mobile phase containing acetonitrile: Phosphate buffer pH 3.5 in proportion of 50:50 v/v was employed with flow rate of1.0 ml/min and eluting medium was monitored at 240 nm. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness for irbesartan. A linear response was observed in the range of 5- 40μg/ml. Linear regression of absorbance on concentration gave equation y = 101.9x + 195.3 with a regression co-efficient r2 =0.993. The method was validated for different parameters as per the ICH guidelines. The degradation studies were carried out by using the developed method. Thus the method was found to be useful for the determination of irbesartan in bulk as well as for dosage forms.

Development and validation of analytical method for Irbesartan and Atorvastatin by simultaneous equation spectroscopic method

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Irbesartan and atorvastatin in synthetic mixture using simultaneous equation Method. In this spectroscopic method, 226.00 nm and 246.00 nm wavelengths were selected for measurement of absorptivity. Both the drugs show linearity in a concentration range of 05-30 ?g/ml at their respective ?max. Accuracy, precision and recovery studies were done by QC samples covering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.033?g/ml and 0.125 ?g/ml for Irbesartan and atorvastatin, respectively. The limit of quantification was 0.1008 ?g/ml and 0.3792 ?g/ml for Irbesartan and atorvastatin, respectively. Recovery of Irbesartan and atorvastatin were found to be 99.75 % and 99.52% respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Development and Validation of Analytical Method for Irbesartan and Atorvastatin by Simultaneous Equation Spectroscopic Method

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Irbesartan and atorvastatin in synthetic mixture usingsimultaneous eqution Method.In this spectroscopic method, 226.00 nm and 246.00 nm wavelengths were selectedfor measurement of absorptivity. Both the drugs show linearity in a concentration range of 05-30 μg/ml at theirrespective λmax. Accuracy, precision and recovery studies were done by QC samplescovering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy,precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.033μg/ml and 0.125 μg/ml for Irbesartan and atorvastatin, respectively. The limit of quantification was 0.1008 μg/ml and 0.3792 μg/ml for Irbesartan and atorvastatin, respectively. Recovery of Irbesartan and atorvastatin were found to be 99.75 % and 99.52% respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid,simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Stability Indicating RP-HPLC Studies for the Estimation of Irbesartan and Amlodipine Besylate in Pharmaceutical Formulations and Identification and Characterization of Degradants Using LC-MS

A simple, specific, accurate, and stability-indicating reversed-phase high-performance liquid chromatography method was developed for simultaneous estimation of irbesartan and amlodipine besylate in pharmaceutical formulations. The chromatographic separation was achieved on a Zorbax CN column using a mixture of 1 mM potassium dihydrogen phosphate (pH 3.0) and acetonitrile (70:30, v/v) as the mobile phase at a flow rate of 0.9 mL/min. Detection was carried out at 240 nm. The calibration curves were linear (R 2 ≥ 0.99) over a concentration range of 6–42 µg/mL for irbesartan and 2–14 µg/mL for amlodipine besylate. The retention times of irbesartan and amlodipine besylate were 9.6 and 7.6 min, respectively. For stability studies, irbesartan and amlodipine besylate stock solutions were subjected to acid, alkali hydrolysis, chemical oxidation, and dry heat degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention times and resolution. To elucidate structures of degradation products, the LC-MS method was used. The proposed method was successfully validated in accordance to the ICH guidelines acceptance criteria.

Estimation of Irbesartan in Bulk and Dosage Forms by New Simple UV Spectrophotometry Using Hydrotropic Technique

Irbesartan, chemically, a non peptide tetrazole derivative, has anti hypertensive property. It is an angiotensin II antagonist that selectively blocks the binding of an angiotensin II to the angiotensin I receptor. In present work, a selective, specific, sensitive and economical hydrotropic agent assisted spectroscopic method using 1M sodium bicarbonate and 2M urea (50:50% v/v), as hydrotropic agent; to increase the solubility of poorly water-soluble Irbesartan, has been developed for the estimation of Irbesartan in Bulk and its pharmaceutical dosage forms. An absorption maximum was found to be at 246.4 nm where sodium bicarbonate, urea and other excipients did not show any absorbance above 228 nm and thus no interference in the estimation. Irbesartan was obeyed Beer’s law in the concentration range from 10-35 μg / ml. Proposed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values with correlation coefficient of 0.9998. The percentage recovery of Irbesartan ranged from 99.4-101.3% in pharmaceutical dosage form. Results of the analysis for accuracy, precision, LOD, LOQ and were found to be satisfactory. The proposed method is simple, rapid and suitable for the routine quality control analysis.