Current Issue : October-December Volume : 2016 Issue Number : 4 Articles : 5 Articles
A simple, sensitive, rapid and precise bioanalytical RP-HPLC method was developed for estimation of albendazole in rat plasma. The work carried out on Shimadzu LC-2010 CHT HPLC system equipped with Purospher® STAR Hibar® 250 mm C18 (4.6 mm × 25 cm, packed with 5 m particles) column with mobile phase containing sodium acetate buffer (pH 4.7): acetonitrile in the ratio 50:50 v/v (1 ml/min) and detection wavelength 298 nm. The retention time of albendazole was found to be 5.5 min. The developed bioanalytical method was found to be linear in concentration range of 0.43-2.60 ng/ml (R2 = 0.9466). The precision study revealed that the percentage cumulative variation was within acceptable limit and accuracy study showed the value of mean percent recovery between 89.73-108.99 %. The albendazole was stable in rat plasma at different storage conditions. The validation parameters of the method met the acceptance criteria. Sufficient stability at LQC and HQC was shown to allow for completion of sample analysis in clinical trials. From the results, it was concluded that developed bioanalytical method can be used for routine analysis of albendazole....
The present study provides a high degree of assurance that a specific process for manufacturing of cilnidipine and chlorthalidone tablets will consistently produce a product meeting its predetermined specifications and quality attributes. It mainly involves the steps to be followed to evaluate and qualify the acceptability of manufacturing process of cilnidipine and chlorthalidone Tablets. The process was limited to the three batches manufactured of specific batch size with specified equipments and control parameters for tablets. It involves all parameters related to the each step were evaluated by respective standard test involved in the manufacturing. Sampling, testing plan and acceptance criteria for each step were monitored. The analytical results of all stages were found to be within acceptable limit. Other test related to compression such as hardness, thickness, disintegration and dissolution for all three batches were found within acceptable limit....
A simple, rapid, economic, sensitive and precise RP-HPLC method has been developed for the simultaneous estimation of ebastine and phenylephrine HCl in tablet. Literature review was done for this combination and there is no reported RP-HPLC method available for estimation of both drugs in combination. An isocratic separation was carried out using C18 column (250×4.6 mm, 5 m particle size) and the mobile phase consisting of 0.02M KH2PO4 Buffer (pH 4.0 (±0.05) is adjusted with using orthophosphoric acid) and methanol in the proportion of 70:30 (v/v). Quantification carried out at a wavelength of 272 nm. Retention time of ebastine and phenylephrine HCl was found to be 5.847 and 3.600 min respectively. The % assay of ebastine and phenylephrine HCl were found to be in range of 99.86-99.95 % and 99.89-99.93 %. The limits of detection and quantification were found to be 0.235, 0.509 μg/ml and 0.71, 1.54 μg/ml respectively....
A new RP-HPLC method for lamivudine has been developed and validated. The developed method was simple and accurate and validated for various parameters as per ICH guidelines. The drug has shown �»max at 226 nm in UV. The linearity concentration range for the drug was found to be 100-500 �¼g/ml and co-relation coefficient was found to 0.998 for RP-HPLC method respectively. The validation parameters as per the ICH guidelines were determined and found to be within the limits....
A simple, specific and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for simultaneous determination of linagliptin and empagliflozine in tablet dosage forms. Chromatography was performed through kromosil (250 x 4.6 mm, 5m) and isocratic elution. Mobile phase containing buffer and acetonitrile in the ratio of 70:30 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was 0.1% OPA buffer with pH 4.8 adjusted by triethylamine maintained with a temperature of 30°C. Optimized wavelength for linagliptin and empagliflozine was 286 nm. Retention time of linagliptin and empagliflozine were found to be 1.920 min and 3.699 min respectively. %RSD of the linagliptin and empagliflozine were 1.0 and 0.94 respectively. All the validation parameters were in the acceptable range. Simultaneously this method applied to determine the degradation products of linagliptin and empagliflozine. The detection wavelength of 286 nm was chosen in order to achieve high sensitivity for quantitative determination of these drugs in solid dosage form. Method can be successfully employed for simultaneous estimation of these drugs in commercial products....
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