June 1, 2023

Hello everyone my name is ranita coronados and mystery source of the evolution of the quality of smf and medication from low american countries my thesis advisor to dr mary turner and my major is biochemistry and some back information that you know i said south central medical products are lesser quality compared to a standard and caffeine medical products are made

Improperly and so to actually see individuals thinking to think that they have the uh correct medication and just being worldwide increasing rates of these legal products that mainly affect low to minimum countries and according to who are going around ten percent of every miracle products women’s currencies are either sub center or counterfeit and according to our

Who are called india one’s largest producers and distributors of pharmaceutical products consumes up to 10 percent of illegal drugs in the world some reason for the increasing incident rates are pursuant profits lack of medical supplies and a lack of rook to boys luckily there are institutions that work to curb the increasing rates and one of these introductions

Is run by the university of third dame college of science which is called depow and which stands for distributed pharmaceutical analysis and depression aims to provide quality electrical chemical screens for countries that do not have the capacity to do so like kenya uganda india nepal and maui and to the right to see the different university colleges that work

With steep and you see that mr college is specialized in analysis as msn and we use a high performance liquid chromotophy system or hplc to analyze the drugs and we use a reverse phase hbc system more specifically for this study we should say hpc shemaster promise lc 28b with spd20a use detector in a four point six times ten the millimeter risk ultra c18 column

To write you can see a simple depiction of how the hplc system is set up so is somewhere so the reverse phase system is run on notion that the column is more potent than the more phase which allows organ molecules to stick to come for one period of time this means that more polar substances are a little faster than non-polar substance so a so first a pump applies

Large pressure to the ammo phase the solvent mushroom throughout the decision phase the column and the column is filled with small and fine particles of silicone polymers are permanent to the soil mixture and throughout the column they’re they’re separated based on polarity and and once when they are fully separated they are detected by the by detector in this case

The uv detector and then a chromogram is is made which is a digital annotation of the separation of the column of the compound that the remaining mold phase and samples are forced into which container to be discarded recycled or served for further examination so the purpose of this study so first one one of the goals is to pass through current systems abilities

Parameters said by deposits since the hbo system needs to have the analytical capacity to run these samples that zebra will provide to them and after the system is passed the our 20 samples probably from the low to middle countries and run them on the system to see if they’re they’re indeed still phenomenal as a symphony and this is if there’s any any need for

A premise of the methodology and the system symbology was run based on it based on the hpc message manuals i’ve given to me the precision so the first person the first area that i need to focus was precision to show the uh reproducibility of the system and to do this i first measured 50 milligrams of film phenomenon and to a 50 milliliter involvement flask and i

Fill that with two to one ratio of a default measure with three portions of water to one percent of hplc grade methanol then this made a stock calculation of one milligram familiar now i thought that to dissolve any large particles within the flask then delete the mixture to a construction at 0.1 and then filter that and place that into a 1.5 centrifuge tube then

I did six catheter injections into the uh hq system to get the intensity values then according to the posted parameters my relative standard deviation should not be greater than two percent and accuracy my relative division was not greater than two percent so this means that the precision portion of the accessibility was passed and then i focused my session on

The linearity of the accessibility to show that the acquired data files fall within a predictable linear um region module and and from steam stock solution from say one question stock solution i prepared a 0.605 punctuation point zero two percent eight point one point twelve point eighteen and point two then i injected those into the h business system gaussian

Intensities and the polynomial on the graph though it is construction versus intensity and according to depot mars my r square should be greater than point nine two and point nine eight actually and you see my r squared is greater than 0.98 which since it is 0.9989 so this means that the learning was passed now focusing my attention on the accuracy range to see

If the measuring concentrations were close to the actual values and the first that means the overdose sample which is 100 150 percent for example 100 percent different sample which is 35 percent and solid blank which is just a default lower mushroom and the 150 percent is equivalent to a 0.5 concentration and a 100 equivalent to 0.1 and thirty five point two

Point and two point zero three five and each of them were run according to sort of overdose normal efficient development and there were one two tests each for a total of twelve injections and then across the intensities and i i quantified the mushroom concentration and according to d-pal the difference of the uh measure concentration from the actual should not

Be greater than two percent and you can see that that none of the percent difference were greater even than one percent so this means that the actual range was passed and that focuses my attention to actually via fibercrafty to show that a spy can be recovered from a sample that was spiked with more active pharmaceutical agreement so to do this i got the 500

Milligram equivalent extra strength sigma fan tablet and many two concentrations are 0.1 milli milligram per milliliter following the same process at measuring form however one of these samples had an extra three percent active form still ingredient to it and then adjective samples into hpc column then i got the values which i will talk about later then i then

After that i focused my attention on the specificity to show that a spike can be required from a degree sample that was also stressed and to a degree sample i picked it for two hours at 60 degrees celsius and follow the same procedure as actually just spike your carving injected that due to the hpc to hpsd system 80 percent recovery for both should between 90 to

10 percent and for the actually via flightcraft it was a 99.7 70 percent so that passed that section and for the the difference for the specificity with 103.53 so that also passed the deposit grammar then zebra also requires a normal chromogram for a 0.1 concentration so you can see that onto right you see that overpowerment frustration it looks around the point

It was around between 2.29 and efficiently around 2.7 it has a tensor around 1 million and the limit detection and lower limitation are not required for this if previous studies have obtained these results and previously done remember college have their team results so that’s why those when they’re run in this study after system stability was done and verified

I focused my attention on between on the deep 20 samples of rep different colors that came in which was either white or pink and so i prepared them following the same procedure i’m first making a socket of one one milligram per milliliter then diluting them to a question of 0.1 and then i made a calibration curve using usb c sim channel with a result of point

Zero two question eight point one point twelve point two to compare my depot samples to to make sure that they fall within the the power set parameters i also made a calibration check congestion using using usp as infernal i concentration of 0.1 to make sure that after every suggestion the hp system will consist of throughout to the left you see that my calorie

Curve has a r squared value of 0.999 r squared which is more than 0.9.98 or square perfect d pal you can see that for my to the right table shows that the uh that deal that the least amount of pearl mass was 54 or 544.69 the greatest west almost 700 milligrams and typically the the pilgrimage should be around 500 milligrams and the peaks and tip and for the and

For the pills after the the leaf mass had a higher average peak attested for the peaking with the most massive uh lowering contestant and they should also have a api dosha around 100 but you see that they are varying between 554 and 539 ever since the every person difference was less was less than 20 percent this means that that they passed it said the parameter

Says indicating that this that the that the 27 were deed as infinite also ran so it’s the comparison of the least mass pill to the most past pill 18b was the most mass pill and the 16p was the most mass with the least mass which had the least mass you see that even though there’s a different intensities they are around the same time which are around 2.4 minutes

Especially around 2.66 and additionally even though there’s a difference intensities since there’s no other peaks this this doesn’t indicate that that the uh the depot samples were indeed as inferential however just that they were that one pillar had some pills have a higher concentration than the other here to write and see the eight calibration checks just in

The dead and since all of them are within two percent percent error this just passed the deposit parameters so the capital check passed meaning that the hp system must consist throughout so discussion for future so uh for discussion so my system simplicity passed means i can move on to the not analyzing the 20 sample sets by by the default and all the 20 samples

Will run twice to make sure that they were consistent so and based on our thoughts i i indicated that all the all the samples were indeed as in front of hybrids they were at different concentrations and my largest limitation was i need to perform all the samples and one large runs then deep doesn’t allow you to you to do one one portion of the run one day and

Official another day otherwise you need to do another separation curve since the system can deviate throughout throughout the day depending on the temperature or or the pressure aligned by the system some improvements that i would like to introduce or to into future stories are use of digital testing gas from target mass spec in case there are differences in the

In systems to determine specifically what what does the difference are and and and typically and also want to indicate um the use of decision testing to just to see if the even though there are either a question microsoft they are the only samples where are symphony one they could be um they could have different reads of the reader probability bio availability

Which could damage the individual so this this testing could be really used and the rest cascom target massback could be used to identify any other empiricies or samples surrounding the hb throughout the hplc data that were required and so any questions can be directed to me my clutch email or i can answer them during the support them and i’d like to acknowledge

Dr dr mary turner for helping me throughout the helping throughout the process and overcoming obstacles thank you

Transcribed from video
Evaluation of the Quality of Acetaminophen Medication from Low- and Middle-Income Countries By Rene TinocoHernandez