Development and validation of spectrophotometric method and paper-based microfluidic devices for the quantitative determination of Amoxicillin in pure form and pharmaceutical formulations.

There is a growing need for easy-to-use, low cost and portable quantitative assays to determine active pharmaceutical ingredients in the pharmaceutical industry. Here, we developed a batch spectrophotometric method and a method employing a paper-based microfluidic device for the estimation of Amoxicillin (AMX) in pure solution and pharmaceutical preparations. The detection depends on the coupling reaction of Amoxicillin with diazotized sulfadimidine (DSDM) in an alkaline medium. The yellow azo dye reaction product was measured at λmax 425 nm and linearity was observed from 2 to 30 mg L-1 with a detection limit of 0.32 mg L-1 and a quantification limit of 1.2 mg L-1 was found. The reaction was then transferred onto the paper-based microfluidic device and a plateau change in color intensity was found above 10 mg L-1. Thus, the paper-based microfluidic device can be applied for the semi-quantitative determination of Amoxicillin in pure solution and commercial pharmaceutical products for rapid screening.

Detection of doxycycline hyclate and oxymetazoline hydrochloride in pharmaceutical preparations via spectrophotometry and microfluidic paper-based analytical device (µPADs).

There is growing demand for simple to operate, sensitive, on-site quantitative assays to investigate concentrations of drug molecules in pharmaceutical preparations for quality assurance. Here, we report on the development of two colorimetric analysis methods for the study the antibiotic doxycycline hyclate (DOX) and the nasal decongestant oxymetazoline hydrochloride (OXY), in solution as well as in their respective formulations. We compare a UV/vis spectrophotometry method with a color change recorded on a microfluidic paper-based analytical device (µPAD). Detection is based on the pharmaceutical compounds coupling with diazotized 4-aminoacetophenone (DAAP) under alkaline conditions to produce colored azo-dye products. These azo-compounds were monitored by absorbance at 425 nm for DOX and 521 nm for OXY, with linear calibration graphs in the concentration range of 0.5-35 mg L-1 (DOX) and 1.0-40 mg L-1 (OXY) and limits of detection of 0.24 mg L-1 (DOX) and 0.32 mg L-1 (OXY). For the µPAD method, color intensity was measured from photographs and a linear increase was observed at concentrations from above approximately 15 mg L-1 for both compounds and up to 35 mg L-1 for DOX and 40 mg L-1 for OXY. The developed methods were also applied to the formulated pharmaceuticals and no interference was found from the excipient. Thus, the paper-based device provides an inexpensive, simple alternative approach for use outside centralized laboratories with semi-quantitative capability.

Evaluation of the novel total artificial heart Realheart in a pilot human fitting study.

Heart failure affects >26 million patients worldwide. Current cardiac devices save lives, but patients suffer complications. Hence, improved devices are needed. Realheart TAH is a novel total artificial heart which has shown promising results in acute pig studies. However, the device design needed to be evaluated in humans. Virtual implantations demonstrated the device fits in two of three patients, but that there was some interference with the left lung. Herein, we used an innovative 3D-printed model with swivelling device components to test the device in human cadavers. Our new method demonstrated how to optimize design to improve the surgical fit.

Hollow fiber liquid-phase microextraction combined with high performance liquid chromatography for the determination of trace mitiglinide in biological fluids.

A hollow fiber liquid phase microextraction (HF-LPME) in conjunction with reversed phase HPLC-UV method was developed for the extraction and determination of trace amounts of the antidiabetic drug, mitiglinide (MIT) in biological fluids. The drug was extracted from 10 mL aqueous sample (donor phase (DP)) into an organic phase impregnated in the pores of hollow fiber, followed by the back extraction into a second aqueous solution (acceptor phase (AP)) located in the lumen of the hollow fiber. Parameters influencing the extraction efficiency including the kind of organic solvent, composition of DP and AP, extraction time, stirring rate and salt addition were investigated and optimized. Under the optimized extraction conditions, high enrichment factors (210-fold), good linearity (5-1000 ng mL(-1)) and detection limit lower than 1.38 ng mL(-1) were achieved. Recoveries of spiked samples were in the range (88.3-96.3%) and (92.0-99.3%) for urine and plasma samples, respectively. The percent relative standard deviation (n=9) for the extraction and determination of three concentration levels (100, 400 and 800 ng mL(-1)) of MIT were less than 10.6% and 13.6% for urine and plasma samples, respectively. The developed method is simple, sensitive and has been successfully applied to the analysis of MIT in biological fluids.

Normal and reverse flow injection-spectrophotometric determination of thiamine hydrochloride in pharmaceutical preparations using diazotized metoclopramide.

Simple and sensitive normal and reverse flow injection methods for spectrophotometric determination of thiamine hydrochloride (THC) at the microgram level were proposed and optimized. Both methods are based on the reaction between THC and diazotized metoclopramide in alkaline medium. Beer's law was obeyed over the range of 10-300 and 2-90 µg/mL, the limits of detection were 2.118 and 0.839 µg/mL and the sampling rates were 80 and 95 injections per hour for normal and reverse flow injection methods respectively. The application of both methods to commercially available pharmaceuticals produced acceptable results. The flow system is suitable for application in quality control processes.