Prediction of saxagliptin stability using a new approach based on Partial Least Squares and Design of Experiments.

The objective of this study was to assess the possibility of applying Partial Least Squares (PLS) statistics with the use of experimental design approach towards stability evaluation of the Saxagliptin drug product. The influences of temperature, time, dose, packaging, batch, and oxygen protection were analyzed for identification of critical factors responsible for degradation of saxagliptin and prediction of impurity levels at various storage conditions. Predicted levels of the impurity DP-2 were lower for at least 0.

Optimization of UPLC Method for Simultaneous Determination of Rosuvastatin and Rosuvastatin Degradation Products.

An ultra-performance liquid chromatographic method for simultaneous determination of rosuvastatin and rosuvastatin degradation products was developed and optimized by using fractional factorial experimental design. Optimized method is capable to accurately determine all potential degradation products of rosuvastatin. During the optimization the effect of four chosen chromatographic factors was evaluated.

Applying the methodology of Design of Experiments to stability studies: a Partial Least Squares approach for evaluation of drug stability.

The aim of the present research is to show that the methodology of Design of Experiments can be applied to stability data evaluation, as they can be seen as multi-factor and multi-level experimental designs. Linear regression analysis is usually an approach for analyzing stability data, but multivariate statistical methods could also be used to assess drug stability during the development phase. Data from a stability study for a pharmaceutical product with hydrochlorothiazide (HCTZ) as an unstable drug substance was used as a case example in this paper.

Quality by design based optimization of a high performance liquid chromatography method for assay determination of low concentration preservatives in complex nasal formulations.

The effects of seven different chromatographic parameters and five sample preparation parameters in a high performance liquid chromatography (HPLC) method for assay determination of benzalkonium chloride (BKC) in a nasal formulation were evaluated using two fractional factorial experimental designs. The design space of the analytical method was modeled using Umetrics Modde software and the optimal method conditions were predicted. The optimum HPLC chromatographic conditions were obtained using a Luna CN column (150 x 4.

Using different experimental designs in drug-excipient compatibility studies during the preformulation development of a stable solid dosage formulation.

Different types of factorial experimental designs can be used in compatibility studies of drug development, where many different factors and their interactions should be evaluated to predict their effects on the degradation of the drug substance under study. All possible main and interaction effects of different potential excipients that can constitute the drug product should be evaluated in order to select the best combination of excipients that give the lowest possible degradation, i.e.

Determination of xanthohumol in hops (Humulus lupulus L.) by nonaqueous CE.

Xanthohumol (XN) is a prenylated chalcone with antimutagenic and anticancer activity from hops. A nonaqueous reverse polarity capillary electrophoretic method for the determination of XN in hop extract was developed and validated. The optimal parameters were a 64.