Abstract
QBD BASED HPLC METHOD DEVELOPMENT AND VALIDATION OF OSELTAMIVIR PHOSPHATE IN API AND PHARMACEUTICAL FORMULATION

Dr. Kalkotwar R. S. and Pramod A. Game*

ABSTRACT

Background: Quality By Design is systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. An essential element of the QbD is the understanding of dependent variables, various factor, and their interaction consequences with the aid of a desired set of test on the response to be analysed. A simple, rapid, selective, and reproducible Quality by Design based high performance liquid chromatography (HPLC) method has been developed and validated for the estimation of Oseltamivir Phosphate in API of Oseltamivir Phosphate tablet. Results: The chromatographic conditions were optimized with the help of Design expert software. The total analysis was carried out by using Waters XBridge C18 (250 mm x 4.6 mm, 5 μm particle size) column. A mobile phase composed of Methanol: Buffer (70: 30 v/v) at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 207 nm. The linearity range used was 8-48 μg/ml and (Rt) was 3.184 min and temperature was adjusted at ambient. The correlation coefficient values were found to be 0.9993. precision studies showed % RSD values less than 2 % for all the selected concentrations. The percentage recovery of Oseltamivir Phosphate was found to be 99.95 – 100.23 additionally mentioned method found satisfactory plus robust at different level of mobile phase, change in pH and wavelength and flowrate. The assay results of Oseltamivir Phosphate were within the limits of 95-105 %. Validation parameters such as specificity, linearity, precision, accuracy, and robustness, limit of detection (LOD) and limit of quantitation (LOQ) were evaluated for the method according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. Conclusion: The Central composite design method is used to determine the number of experiments to be evaluated for the optimization of the variables and responses. The experimental design describes the relationship between mobile phase and pH at different levels and response observed were retention time, theoretical plate and tailing factor with the help of design expert software program. The QbD approach in method development used for the better understanding of method variables at different levels. The developed method was successfully used for the quantitative analysis of commercially available dosage form.

Keywords: QbD, HPLC, Oseltamivir Phosphate, Method Development, Validation.


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