Résumé
A simple and sensitive visible spectrophotometric method has been developed for the determination of Atorvastatin (ATV) in pure form and in tablets using Sulfo-Phospho-Vanillin reagent.The methods is based on the reaction of atorvastatin with sulphuric acid to form carbonium ion,which subsequently react with vanillin phosphate ester and measuring the resulting purple coloured complex at 414 nm. Under the proposed optimum condition, Beer’s law was obeyed at the concentration range of 30-100μg/ml. The result of analysis of tablet was found to be 99.81 %. The good results of recovery studies showed that the co-formulated substances did not interfere with the determination. The method was validated according to ICH guidelines by performing linearity, accuracy, and precision, limits of quantification, limit of detection and selectivity.
Résumé
A novel, simple, fast and reproducible UV spectrophotometric method was developed using 2M urea solution as hydrotropic solubilizing agent for the estimation of poorly watersoluble drug amlodipine besylate in bulk and in pharmaceutical dosage form. Various organic solvents such as methanol, chloroform, dimethyl formamide and acetonitrile have been employed for solubilization of poorly water-soluble drugs to carry out spectrophotometric analysis. Drawbacks of organic solvents include their higher cost, toxicity and pollution. Hydrotropic solubilization may be a proper choice to preclude the use of organic solvents. It involve the addition of large amount of a second solute to increase the aqueous solubility of the first solute. Amlodipine exhibits absorption maximum at 243 nm. Urea did not show any absorbance above 225 nm and thus no interference in the estimation of drug was seen.Beer’s law was found to be obeyed in the concentration range of 5-25μg/mL. In this method, there is no interference from any common pharmaceutical additives and diluents. The correlation co-efficient (' r ' value) for amlodipine was0.99863.The results of analysis have been validated as per ICH guidelines. The percentage recoveries obtained for amlodipine ranges from 99.94 to 99.96. The method is accurate, precise and economical.
Résumé
A simple, specific, rapid, precise and robust HPLC method has been developed for the quantitation of valsartan in tablet dosage form on a C18 column (250 x 4.6 mm) using a mobile phase consisting of ammonium dihydrogen phosphate buffer : methanol (33.5:66.5) adjusted to pH 3 with formic acid at a flow rate of 1.0 ml/min and detection at 265 nm. The retention time of valsartan was found to be at 11.9 min. The validation of above method was also done. Percentage label claim of the tablet formulations were found to be 100.8%. So the proposed method provides a faster and cost effective quality control tool for routine analysis of valsartan from formulations.
Résumé
A new, simple, accurate, and precise high-performance thin-layer chromatographic (HPTLC) method has been established for quantitative analysis of valsartan in tablet formulations. Standard and sample solutions of valsartan were applied to precoated silica gel G 60 F254 HPTLC plates and the plates were developed with chloroform: acetonitrile: toluene: glacial acetic acid, in the ratio 1:8:1:0.1 (v/v) (v/v), as mobile phase. UV detection was performed at 254 nm. The retention factors of valsartan was 0.65. The calibration plot for Valsartan standard was linear with r =0.9999, slope = 5.328 and intercept=356.9. The limit of detection and limit of quantitation of Valsartan were found to be 5and 16 ng per spot respectively. The percentage recovery was found to be 99.37% for Valsartan. The method showed good repeatability and recovery with relative standard deviation less than 2. Method was validated in accordance with the requirements of ICH guidelines and was shown to be suitable for purpose. The method is selective and specific can be used for determination of the routine analysis of valsartan in tablets. Tablet excipients did not interfere with the chromatography.