Quality by Design: Design of Experiments Approach Prior to the Validation of a Stability-Indicating HPLC Method for Montelukast

This paper describes a systematic design of experiments (DoE) approach by applying the principle of quality by design (QbD) to determine the design space for a stability-indicating HPLC method prior to validation. By employing DoE, a simultaneous multivariate approach was carried out for mobile phase pH, flow rate, percentage of organic content and column temperature. A two-level fractional factorial design (2^4?1 + 2 center points = 10 experiments) was employed and statistical analysis of the experimental data uncovered the significant influential chromatographic factors. The experimental data for USP tailing and resolution were analyzed statistically to screen the chromatographic factors. This approach determined the most influential chromatographic factors. During this process, inferences were evaluated from various data tables, for example, analysis of variance, summary of fit, lack of fit, and parameter estimates. The study also explained various plots such as actual vs. predicted plot, Pareto plot, and prediction profiler. The acceptable range of the chromatographic factors was displayed as a Contour plot defining the ‘design space’ of the method. The range of operating conditions that guarantee a satisfactory QbD was deduced to finalize the method prior to validation. The method is simple, rapid, and robust for the determination of montelukast in montelukast sodium oral granules dosage form. The method was validated according to ICH guidelines for accuracy, precision, linearity, range, specificity, ruggedness and robustness (one factor varied at a time). The method has been successfully transferred to the quality control department for quality analysis of manufactured batches and stability samples.     

Integrated Contention Resolution and Control Algorithm for Optical Burst Switched Networks

Abstract

This article compares the conventional and proposed integrated contention resolution and control algorithm in optical burst switching with respect to burst loss probability and network throughput. Results have shown that the proposed approach behaves well in practice and responds quickly to any change in network status, while improving the overall network performance. It is shown that the proposed algorithm (ICRCA) not only provides significantly better burst loss performance than the conventional algorithms, but is also void of any packet re-orderings.     

ChemInform Abstract: High Pressure Phase Transitions in Scheelite Structured Fluoride: ErLiF4.

ErLiF₄ is prepared by solid state reaction of stoichiometric amounts of LiF and ErF₃ (1.