Laboratory
safety teams (LSTs), led by graduate student and postdoctoral
researchers, have been propagating across the U.S. as a bottom-up
approach to improving safety culture in academic research laboratories.
Prior to the COVID-19 pandemic, LSTs relied heavily on in-person projects
and events. Additionally, committed Champions from the ranks of safety
professionals and faculty were critical to their operation and continued
expansion. As was the case for many existing systems, the COVID-19
global crisis served as an operational stress test for LSTs, pushing
them to unexpected new limits. The initial spread of COVID-19 brought
with it a shutdown of academic institutions followed by a limited
reopening that prohibited in-person gatherings and disrupted standard
lines of communication upon which LSTs relied. Safety professionals
and faculty members were required to take on new duties that were
often undefined and time-consuming, substantially impacting their
ability to support LSTs. In this case study, we report the impact
of this operational stress test on 12 LSTs, detailing the adaptive
means by which they survived and highlighting the key lessons learned
by the represented LST leaders. The key takeaways were to spend time
nurturing relationships with a diverse array of Champions, securing
stable funding from multiple sources, and networking with members
of LSTs from different institutions to strengthen moral support and
broaden ideation for common challenges.
An accurate, sensitive, precise and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, using a UV detector for analysis of paracetamol and tramadol hydrochloride in combination tablets has been developed and validated. The best separation was achieved on Zorbax SB C 18 250 mm × 4.6 mm, 5-µm particle, with 30: 70 (v/v) of acetonitrile: 1% trifluoroacetic acid as the mobile phase, at a flow rate of 1.5 ml/min. The detection wavelength was set at 271 nm. The method was validated according to the International Conference on Harmonization (ICH) guidelines. The response was a linear function of concentration over the range of 325 -2112.50 ppm for paracetamol and 37.5 -243.8 ppm for tramadol hydrochloride. The correlation coefficient (r 2 ) was found to be 0.9998 for paracetamol and 0.9961 for tramadol hydrochloride. The limits of detection and quantitation were found to be 35.80 ppm and 108.49 ppm for paracetamol and 4.14 ppm and 12.54 ppm for tramadol hydrochloride. The drug was subjected to hydrolytic and thermal stress and was found to decompose slightly under both acidic and basic hydrolytic stress conditions and also under thermal stress. The degradation products produced as a result of the hydrolytic and thermal stress did not affect the detection of both paracetamol and tramadol hydrochloride, and the assay could thus be regarded as stability-indicating. The developed method was used to assay a sample of fixed-dose combination tablets and was found to be suitable for application in the analysis of fixed-dose combination tablets of paracetamol and tramadol hydrochloride for quality control purposes.
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