A multivariate quantification of Box‐Behnken design assisted method development and validation of dextromethorphan hydrobromide and desloratadine simultaneously by reverse‐phase HPLC in in‐house syrup formulation

Abstract

An innovative high‐performance liquid chromatography assay method was developed and validated for quantification of dextromethorphan hydrobromide and desloratadine simultaneously in monophasic liquid formulation by preparing syrup containing 30 mg/5 mL of dextromethorphan hydrobromide and 1.2 mg/mL of desloratadine. The chromatographic severance was executed by gradient solution A and B. The composition of buffer solution A contained 0.05 M monobasic potassium, then 1 mL triethylamine was added to it and the pH was adjusted to 2.3 with orthophosphoric acid. Methanol was used as solution B. The gradient elution was executed with Kromasil C8 (250 mm × 4.6 mm) column having 1.5 mL/min flow rate and 20 µL injection volume with UV‐estimation at 254 nm for dextromethorphan hydrobromide and DES. The present research was planned according to Box‐Behnken design by utilizing design expert software, using four factors such as column temperature (A), flow rate (B), mobile phase–organic phase (C), and pH (D); correspondingly the selected response variables were resolution between A and B, that is, desloratadine and methyl paraben (Y1), tailing of dextromethorphan hydrobromide (Y2), and tailing of desloratadine (Y3). The parameters such as system suitability, linearity, accuracy, precision, robustness, limit of detection, limit of quantitation, and ruggedness were analyzed to validate the developed method in accordance with current regulatory guidelines.

Efficient optimization and development of two methods for the determination of acrylamide in deep‐frying oil by liquid chromatography–tandem mass spectrometry: Application of multifactor analysis assessment strategy

“…From the relative contribution analysis in Figure 5, the evaluation model could not only provide quantitative evaluation results but also give the proportion of different indices, which was not provided by the reported experimental design methods [26]. With the application of the assessment model in QuEChERS, we could notice that the weight of the five indicators determined by information entropy varied among experiments.…”

“…A variety of experiments should be conducted based on variable factors, in order to further select and optimize the appropriate experimental protocol. The proposed evaluation methodologies, including multivariate experimental design [25,26], were commonly based on the study of single performance indicators, such as recoveries (REs) [22] and matrix effects (MEs) [27,28], lacking comprehensive information on the efficiency of the method and failing to account for interactions factors. Besides, the appearance of extracts, the removal efficiency of pigment [29], and the gravimetry of whole matrix content [30] were mainly used to evaluate the pretreatment efficiency of extracts of high matrix content.…”

Statistically Optimized and Box-Behnken Design Assisted Method Development and Validation of an Antipsychotic Medication Olanzapine and Its Related Impurities by Reverse-Phase HPLC-Uv Spectroscopy

“…Robustness parameters were estimated by implementation of experimental design. System suitability was carried out as per USP on an immediately prepared standard solution and evaluating parameters were determined by using above chromatographic conditions for assay [14][15][16][17][18].…”

Diastereoisomer separation of silybin A and silybin B by semi‐preparative liquid chromatography using Box–Behnken design

“…Response surface methodology (RSM) [37,38] has been applied for the characterization of acidic mixtures [39,40] and basic mixtures [41] on HPLC. This technique can be used in research concerning natural products [42] in place of traditional experimental designs that make use of a one-variable-at-a-time design.…”