A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of atenolol and indapamide from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, methanol and water (adjusted to pH 2.7 with 1% orthophosphoric acid) in the ratio of 80:20. The flow rate was 1 mL/min and effluent was detected at 230 nm. The retention time of atenolol and indapamide were 1.766 min and 3.407 min. respectively. Linearity was observed in the concentration range of 12.5-150 µg/mL for atenolol and 0.625-7.5 µg/mL for indapamide. Percent recoveries obtained for both the drugs were 99.74-100.06% and 98.65-99.98% respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of atenolol and indapamide from their combined dosage form.
Objectives: This research work is aimed to develop bio relevant dissolution method by simulating human gastrointestinal condition at post-prandial state. The quality control dissolution procedure for modified release product using simple buffers of specific pH is not adequate for prediction of in vivo performance. Methods: Percentage of drug absorbed is derived by deconvolution of drug plasma concentration at post-prandial condition using Wagner-Nelson deconvolution method. Quality control dissolution test is performed using office of generic drugs recommended dissolution method. Bio relevant dissolution method is developed using USP Apparatus 3 (reciprocating cylinder), with quality by design approach. A full factorial design of experiment study is performed for optimization of dips per minute and media volume. Separate dissolution method is developed for tamsulosin and dutasteride, since the formulation design and release profile are different for both drugs. Results: The dissolution profile obtained using quality control procedure is observed faster in comparison to percentage of drug absorbed. The bio relevant dissolution method developed for tamsulosin part is, 250ml of Fed state simulated change over dissolution media with 15DPM, based on desirability factor 0.8767 and for dutasteride part is, 100ml of pH 6.5 Fed state simulated intestinal fluid with 20DPM, based on desirability factor 0.5836, achieved from multiple response optimizations. The dissolution results are comparable to percentage of drug absorbed. The regression coefficient (R 2) value of 0.998 and 0.982 demonstrates a very good in vitro/in vivo correlation under post-prandial condition for tamsulosin and dutasteride respectively. Conclusion: The developed method shall be used as a predictive in vitro tool for evaluation of in vivo performance under post-prandial condition.
An accurate and precise method was developed and validated for the simultaneous estimation of the Dolutegravir and Rilpivirine in Tablet dosage form. Chromatogram was run using Agilent C 18 column (4.6x150mm, 5µm) with mobile phase containing KH 2 PO 4 buffer of pH 3.5 and Acetonitrile in the ratio of 45:55 v/v was pumped through column at a flow rate of 1mL/min. Temperature was maintained at 30 • C. Selected wavelength was 240.0 nm. Retention time of Dolutegravir and Rilpivirine was found to be 2.239 min and 2.899 min respectively. %RSD of the Dolutegravir and Rilpivirine for system precision was found to be 0.9 and 0.6 respectively. Accuracy was performed in triplicate and the % Recovery was obtained as 99.33% and 100.5% for Dolutegravir and Rilpivirine respectively. LOD, LOQ values for Dolutegravir was 0.2 µg/mL, 0.6 µg/mL and for Rilpivirine was 0.02, 0.06 µg/mL respectively. So, the method developed was simple, accurate and reproducible can be adopted in regular Quality control test in pharmaceutical Industry.
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