Simultaneous determination of amlodipine besylate and benazepril hydrochloride in pharmaceutical dosage form by LC (original) (raw)
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HPTLC Method for the Simultaneous Determination of Amlodipine and Benazepril in Their Formulations
Journal of Chromatographic Science, 2005
A new, simple, precise, rapid, and selective high-performance thin-layer chromatographic (HPTLC) method is developed for the simultaneous analysis of amlodipine and benazepril in pharmaceutical formulations. The method uses zolpidem as an internal standard (IS). The stationary phase used is silica gel 60 F 254 prewashed with methanol. The mobile phase consists of an ethyl acetate-methanol-ammonia solution (8.5:2.0:1.0, v/v/v). Detection and quantitation are performed densitometrically at λ = 254 nm. The R f values of amlodipine, benazepril, and zolpidem (IS) are 0.58, 0.50, and 0.78, respectively. The limits of detection of amlodipine and benazepril are 0.02 and 0.2 µg; linearity ranges are 0.1-0.8 and 0.2-2.0 µg; and the percentage recoveries are 99.79% and 100.25%, respectively.
International Journal of Pharmacy and Pharmaceutical Sciences, 2019
Objective: The objective of this study was to develop and validate a novel ion-pair liquid chromatography method, in order to separate and assay of amlodipine/benazepril combination in capsules. This method was a fast, practical and additional choice in quality control laboratories. Methods: The chromatographic conditions comprised of a classical C18-type stationary phase (250 × 4.6 mm, 5μ), with a mobile phase consisting of: 45% of 10-3 Results: The method was validated for linearity with correlation coefficients very close to one, the accuracy with mean recovery values between 95.0-105.0%, precision with relative standard deviations of the calculated concentrations less than 5.0% and specificity in the presence of degradation products and excipients. M of cetrimide and 55% acetonitrile. The flow rate was 1 ml/min; the detection wavelength was at 242 nm, under ambient temperature. Conclusion: The results presented in this paper showed that the developed method was fast and applicable, for the separation and determination of amlodipine/benazepril combination in capsules.
Arabian Journal of Chemistry
High-performance liquid chromatographic (HPLC) and UV spectrophotometric methods were developed and validated for the quantitative determination of amlodipine besylate (AM) and benazepril hydrochloride (BZ). Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines. The RP-HPLC method was developed by the isocratic technique on a reversed-phase Shodex C-18 5e column. The retention time for AM and BZ was 4.43 min and 5.70 min respectively. The UV spectrophotometric determinations were performed at 237 nm and 366 nm for AM and at 237 nm for BZ. Correlation between absorbance of AM at 237 nm and 366 nm was established and based on developed correlation equation estimation of BZ at 237 nm was carried out. The linearity of the calibration curves for each analyte in the desired concentration range was go...
Journal of chromatographic science, 2009
An accurate, sensitive, and reproducible high-performance liquid chromatographic method for the quantitation of amlodipine besylate in human plasma has been developed and validated. The drug, internal standard, and major metabolite were eluted from a C 18 hypersil HyPurity column (3 µm, 3.9 mm i.d. × × 150 mm) at room temperature with a mobile phase consisting of acetonitrile-potassium dihydrogen phosphate buffer (0.05 M) and acetic acid (62:38:0.1) with the pH adjusted to 3.5 using phosphoric acid. The flow-rate was 1.8 mL/min. The limit of detection was 1.0 ng/mL, and the limit of quantification of amlodipine besylate in plasma was 10 ng/mL. The intra-and inter-day precisions showed coefficients of variation ranging from 5.98-11.4% and from 5.60-11.74%, respectively at three different levels of concentration. The averages of the absolute and relative recoveries were found to be 96.74-98.51% and 95.96-100.71%, respectively. Stability studies showed that amlodipine besylate is stable for at least 2 months in plasma after freezing at -20°C. The method was successfully applied for a pharmacokinetic study and for the determination of commercial amlodipine tablet content. . Chemical structure of amlodipine.
Investigations and HPLC Assay of Model Formulations Containing Amlodipine Besylate and Lisinopril
2013
This paper describes the development and validation of a high-performance liquid chromatographic analytical procedure for simultaneous determination of Amlodipine Besylate (AML) and Lisinopril (LIZ) in model tablet formulations. The separation was achieved with a C18 (250 mm x 4.6 mm, 10 µm) column, at room temperature in an isocratic mode, with the mobile phase containing acetonitrile and 0.5 M sodium acetate buffer (25:75). The flow rate was 1.5 ml/min and the eluent was monitored at 215 nm. The selected chromatographic conditions were found to effectively separate Amlodipine Besylate and Lisinopril, with retention times of 6.67 min and 12.00 min, respectively. The method was validated for specificity, linearity, precision, accuracy, LOD and LOQ. The calibration curves were linear in the concentration range of 5.00-40.00 µg/ml for both AML and LIZ. The intra- and inter-day relative standard deviations for both the components were <2.0 %. The analytical procedure was applied in ...
Analytical method development and validation of Amlodipine besylate in tablet dosage form
Journal of Drug Delivery and Therapeutics
The accurate and precise HPLC analytical method validated for the determination of Amlodipine besylate in pharmaceutical dosage form.The chromatographic separation is carried out on shimadzu HPLC system (LC-2010 CHT) with UV Vissible detector and C18(150mm x3.9 mm) 5 μm Column. The Mobile phase consists of Acetonitrile: Methanol: PH 3.0 Buffer (15 V: 35 V: 50 V) , at the flow rate of 1.0 ml/min and elutes were monitoring at 237 nm. The observed retention time for Amlodipine besylate was 10.8 min. The % RSD for system precision was 0.41 % and Method precision was 0.58 %. The method was found to linear (R=0.99996) in the Concentration range of 35-105 μg/ml (50 to 150%). The accuracy was in between 99.50-99.91%. Keywords: HPLC, Correlation coefficient, System suitability, Bias, % RSD and ICH guidelines
American Journal of Analytical Chemistry, 2013
A stability indicating LC method was developed for the simultaneous determination of Amlodipine and Benazepril capsules in pharmaceutical dosage form. Efficient chromatographic separation was achieved on Symmetry C 18 stationary phase with simple combination of amobile phase containing 750 mL of DI Water, 250 mL of Acetonitrile and 2 mL of Octylamine into suitable container with adjusted pH to 2.50 ± 0.05 with the aid of Ortho phosphoric acid delivered in an isocratic mode and quantification was carried out using UV detection at 240 nm at a flow rate of 1.0 mL•min −1 with an injection volume of 20 μl and ambient column temperature. This method is capable to detect both the drug components of Amlodipine and Benazepril in presence of their degradation products (Amlodipine Imp-A and Benazepril Impurity-C) with a detection level of 0.05%. Amlodipine/Benazepril in their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the samples were analysed. Peak homogeneity data of Amlodipine and Benazeprilis were obtained using PDA detector, in the stressed sample chromatograms, demonstrating the specificity. The method shows excellent linearity over a range of 0.05%-2.0% for Amlodipine, Amlodipine Impurity-A and 0.05%-5.0% for Benazepril and Benazepril Impurity-C. The correlation coefficient for Amlodipine and Benazepril is 1. The relative standard deviation was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of Amlodipine and Benazepril in pharmaceutical preparations. The developed HPLC method was validated with respect to linearity & range, accuracy, precision and robustness.
Journal of advanced scientific research, 2023
The purpose of this study was to develop and validate a simple, sensitive, accurate, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amlodipine besylate and lisinopril in a Tablet dosage form. The chromatographic measurement was performed on a Phenomenex C18 (250 × 4.6 mm, 5um) column with an optimised Acetate buffer mobile phase: Methanol (65:35). The flow rate was one ml/min, and the detecting wavelength was 221 nm. Triethanolamine was used to adjust the pH to 5. In the concentration range of 4-20 ug/ml, amlodipine besylate and lisinopril showed a linear response of the suggested approach. The correlation coefficients ('r' values) for amlodipine besylate and lisinopril were 0.9998 and 0.9995, respectively, and the retention times were 3.279 for amlodipine besylate and 6.124 for lisinopril, respectively. The developed chromatographic technique was validated for specificity, linearity, precision, accuracy, LOD, and LOQ using ICH Q2(R1) criteria. The analysis results have been validated in accordance to ICH guidelines.
This method described for the successful separation of a beta blockers with amlodipine by RP-HPLC on a C18 column with UV detection. One of the key goals of High Performance Liquid Chromatography technique is to achieve a consistent and reproducible separation. A simple, precise, selective and sensitive HPLC method was developed and validated for determination of five anti-hypertensive agents, atenolol hydrochloride, metoprolol succinate, propranolol hydrochloride, amlodipine besylate and nebivolol hydrochloride with application to estimation of amlodipine besylate. RP-HPLC method was developed by using Welchrom C18 column (4.6 mm i.d. X 250mm, 5µm), Shimadzu LC-20AT ProminenceLiquid Chromatograph. The mobile phase composed of 10mM Phosphate buffer (pH3.0, adjusted with triethylamine): acetonitrile (50:50, v/v). The flow rate was set to 1.0ml/min with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Visible detector. This method provides effective and reproducible separation of five anti-hypertensive agents less than 6 minutes. The retention times of atenolol hydrochloride, metoprolol succinate, propranolol hydrochloride, amlodipine besylate and nebivolol hydrochloride were found to be 2.310 min, 2.830 min, 3.473 min, 4.260 min and 4.960 min respectively. The statistical validation of the developed method was carried out according to ICH guidelines. Amlodipine besylate was found to give linear response in the concentration range of 2-10µg/ml. Recovery studies were performed to ascertain the accuracy by standard addition method and average recovery was found to be 99.83-100.40%. The LOD and LOQ were found to be 0.2251µg/ml and 0.6823µg/ml respectively. The developed method can be used for routine quality control analysis of amlodipine besylate in pharmaceutical tablet dosage form. It can also be extended for the determination of other above mentioned most commonly prescribed anti-hypertensive agents. The analysis yields a simple, rapid analysis, reduction in runtime, with excellent peak shape, high resolution as well as outstanding reproducibility.