Development and Validation of a Stability-Indicating UPLC Method for the Determination of Hexoprenaline in Injectable Dosage Form Using AQbD Principles

A novel and efficient stability-indicating, reverse phase ultra-performance liquid chromatographic (UPLC^®) analytical method was developed and validated for the determination of hexoprenaline in an injectable dosage form. The development of the method was performed using analytical quality by design (AQbD) principles, which are aligned with the future requirements from the regulatory agencies using AQbD principles. The method was developed by assessing the impact of ion pairing, the chromatographic column, pH and gradient elution. The development was achieved with a Waters Acquity HSS T3 (50 × 2.1 mm i.d., 1.8 µm) column at ambient temperature, using sodium dihydrogen phosphate 5 mM + octane-1-sulphonic acid sodium salt 10 mM buffer pH 3.0 (Solution A) and acetonitrile (Solution B) as mobile phases in gradient elution (t = 0 min, 5% B; t = 1 min, 5% B; t = 5 min, 50% B; t = 7 min, 5% B; t = 10 min, 5% B) at a flow rate of 0.5 mL/min and UV detection of 280 nm. The linearity was proven for hexoprenaline over a concentration range of 3.50–6.50 µg/mL (R² = 0.9998). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability and injectable dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with enhanced knowledge, which can eventually lead to a reduced regulatory risk, high quality data and lower operational costs.     

On the dimension of the attractor for a perturbed 3d Ladyzhenskaya model

We consider the so-called Ladyzhenskaya model of incompressible fluid, with an additional artificial smoothing term ?Δ³. We establish the global existence, uniqueness, and regularity of solutions. Finally, we show that there exists an exponential attractor, whose dimension we estimate in terms of the relevant physical quantities, independently of ? > 0.     

On Martingale Approximation of Adapted Processes

We show that the existence of a martingale approximation of a stationary process depends on the choice of the filtration. There exists a stationary linear process which has a martingale approximation with respect to the natural filtration, but no approximation with respect to a larger filtration with respect to which it is adapted and regular. There exists a stationary process adapted, regular, and having a martingale approximation with respect to a given filtration but not (regular and having a martingale approximation) with respect to the natural filtration.     

On the Weak Invariance Principle for Non-Adapted Sequences under Projective Criteria

In this paper we study the central limit theorem and its weak invariance principle for sums of non-adapted stationary sequences, under different normalizations. Our conditions involve the conditional expectation of the variables with respect to a given σ-algebra, as done in Gordin (Dokl. Akad. Nauk SSSR 188, 739–741, 1969) and Heyde (Z. Wahrsch. verw. Gebiete 30, 315–320, 1974). These conditions are well adapted to a large variety of examples, including linear processes with dependent innovations or regular functions of linear processes.     

Factorizations of complete graphs into caterpillars of diameter 5

We examine factorizations of complete graphs K_2n into caterpillars of diameter 5. First we present a construction generalizing some previously known methods. Then we use the new method along with some previous partial results to give a complete characterization of caterpillars of diameter 5, which factorize the complete graph K_2n.     

A boundary element method for homogenization of periodic structures

Homogenized coefficients of periodic structures are calculated via an auxiliary partial differential equation in the periodic cell. Typically, a volume finite element discretization is employed for the numerical solution. In this paper, we reformulate the problem as a boundary integral equation using Steklov–Poincaré operators. The resulting boundary element method only discretizes the boundary of the periodic cell and the interface between the materials within the cell. We prove that the homogenized coefficients converge super-linearly with the mesh size, and we support the theory with examples in two and three dimensions.     

1.1 Grundlagen, methoden, apparate, reagentien, automation, datenverarbeitung

Ohne Zusammenfassung     

1.2 Inorganic analysis

Abstracts1 General analytical chemistry

1.2 Inorganic analysis     

1.2 Inorganic analysis

Abstracts1 General analytical chemistry

1.2 Inorganic analysis