Current Issue : April - June Volume : 2017 Issue Number : 2 Articles : 5 Articles
The research into the separation of drug enantiomers is closely related to the safety and\nefficiency of the drugs. The aim of this study was to develop a simple and validated HPLC method\nto analyze cetirizine enantiomers. In the case of liquid dosage forms, besides the active substance\nin large amounts there are usually also inactive ingredients such as methyl- and propylparaben.\nUnfortunately, these compounds can interfere with the analyte, inter alia during chiral separation\nof the analyte enantiomers. The proposed innovative two-step liquid-liquid extraction procedure\nallowed for the determination of cetirizine enantiomers (along with M and P parabens) also in\nliquid dosage forms. The main focus of this study was the chromatographic activity of cetirizine\ndihydrochloride on the proteinate-based chiral stationary phase. The chromatographic separation\nof cetirizine enantiomers was performed on an immobilized human serum albumin (HSA) column\nfor the first time. Measurements were performed at a wavelength of 227 nm. Under optimal\nconditions, baseline separation of two enantiomers was obtained with 1.43 enantioseparation factor\n(�±) and 1.82 resolution (Rs). Finally, the proposed method was successfully applied to the selected\npharmaceutical formulations....
Two simple, precise and easy methods were successfully developed for the estimation of glimepiride in bulk and pharmaceutical dosage forms. The first method was based on UV-spectrophotometry, which is linear in the concentration range of 3-18 µg/ml at maximum absorbance (λ max) 228.4 nm. The correlation coefficient was found to be 0.9998. The accuracy of the method was ranged from 100.20 to 101.39%. The average percent relative standard deviation (%RSD) for precision was found to be 0.39%. The reproducibility of the method was determined based on ruggedness was found to be 0.84%. The second method was based on reversed-phase high-performance liquid chromatography (RP-HPLC) using methanol: phosphate buffer pH 4 (50:50 v/v) with 0.5 ml/min flow rate. The detector response was carried out at 229 nm. The average retention time for the drug was obtained 2.47 min. The calibration curves were linear from 10-50 µg/ml. The accuracy of the method was determined by percent recovery studies ranged from 98.6 to 99.9%. Mean intra - and inter-day assay relative standard deviations were 0.20 and 0.086%. Ruggedness and robustness were also calculated and found not more than 2%. The developed methods were applied successfully for the analysis of drug in its dosage forms and validated according to ICH guidelines....
A simple, precise and cost effective visible spectrophotometric method was developed for estimation of racecadotril in capsule dosage form. The method is based on the formation of drug into an orange colored species upon the addition of an acidified ferric chloride solution and the absorption maxima of these coloured species was found to be 456 nm. Calibration curve was linear over the range of 10 μg-2000 μg/ml. The % assay of drug was found to be 100.84%. The performance of the method was validated according to ICH guidelines. The method can be applied for determination of drug in its capsule dosage form without any interference from excipients. The proposed method is suitable for routine quality control analysis....
The chiral separation of ofloxacin racemate by ligand exchange chromatography was studied and method was\ndeveloped. A kromstar ODS column was used with the mobile phase consisting of a methanolââ?¬â??water solution (containing\ndifferent concentrations of L-isoleucine and copper sulfate as chiral mobile phase additives) at flow rate of 1 ml/min. The effect\nof different mobile phase parameters such as concentrations of chiral selector, bivalent copper ions, organic modifier and\ntemperature and flow rate on enantio separation was evaluated; the results showed that effect of different mobile phase\nparameters was strongly inter dependent. Under the optimized conditions (methanol/ water 13:87 v/v, containing 6 mmol/dm3\nL-isoleucine and Cu++ at 1.5 mmol/dm3), baseline resolution of the ofloxacin enantiomers was obtained with resolution of 1.65\nin less than 15 min....
In the present work one simple and sensitive UV spectrophotometric method have been developed for the\nquantitative estimation of mefenamic acid and tizanidine hydrochloride in combination. For this dual wavelength method, 222\nnm and 237 nm were selected as �»1 and �»2 for the determination of mefenamic acid and 240 nm and 272 nm were selected as �»3\nand �»4 for the determination of tizanidine hydrochloride. The method was validated with respect to linearity, precision,\naccuracy, LOD and LOQ with analytical method validation guideline. Linearity was observed in the concentration range of 0.64-\n3.84 �¼g/ml for mefenamic acid and 1-6 �¼g/ml for tizanidine hydrochloride. The % recovery of mefenamic acid and tizanidine\nhydrochloride was found to be 98.87�±0.0143 - 101.4�±0.0213. The % RSD for intraday precision and interday precision were\nfound to be less than 2 which confirms that the method was precise....
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