Overview on Paracetamol Drug

Various Parameters dealing with the Chemistry, Synthesis, Sale and consumption, Manufacturers and testing methods of Paracetamol drug in brief.

1. A REPORT ON PARACETAMOL Guided by: Presented by: Dr. Vijender Singh Ayush Sharma

2. Objective: To study the quality standards of 4 different brands of paracetamol tablet. To perform different testing parameters for the evaluation of different brands of Paracetamol .

3. INTRODUCTION Paracetamol synthesized by Harmon Nothrop in 1878, also known as acetaminophen is used to treat pain and fever. It is also used in treatment of Headache, Toothache, lower back pain and menstrual pain. It is a weak inhibitor of PG synthesis of COX 1 and COX 2 cell systems. Overdose may lead to hepatic failure, metabolic acidosis and hepatocellular encephalopathy.

4. CHEMISTRY Paracetamol is an aromatic compound containing an -OH group and –CONHR group. Paracetamol is prepared from phenol in a 3 step process: 1. Nitration 2. Reduction 3. Formation of Amide. The presence of activating group makes the bezene ring highly reactive towards electrophilic aromatic substitution reaction.

5. SYNTHESIS 1. Nitration of Phenol 2. Reduction of Nitro to amine

6. 3. Formation of Amide

7. SALE AND CONSUMPTION The pharmaceutical industry in India ranks 3 rd in world terms of volume and 14 th in terms of value. The global paracetamol market is expected to reach US$ 1,049.7 mn by 2022 as compared o its valuation of US$ 900.2 mn in 2014.

8. MANUFACTURERS IN INDIA S.No . Brand Name Composition Company Packing MRP Rs. 1. CALPOL Paracetamol 500mg Glaxo smith kline 10 9.49 2. CROCIN Paracetamol 500mg Glaxo smith kline 10 6.9 3. PARACIP Paracetamol 1000mg/100ml Cipla 100ml N.A 4. PYREXON 650 Paracetamol 650mg Wockhardt 6 8.10 5. T- 98 TAB Paracetamol 500mg Mankind 10 7.5 6. NICETAMOL Paracetamol 500mg Dr. Reddy’s Labs 10 NA

9. TESTING OF PARACETAMOL 1. Weight Variation Test : As per U.S.P weight variation limit for tablet having weight more than 324 mg is 5% and result shows that all 20 tablets of 4 different brands are having weight variation less than 5% which proves that 4 brands available in market passed official weight variation test . 2. Friability Test : The official permissable limit for friability is 1%. The r esult showsthat all 4 brands of PCM are in pharmacopeial limits. It is performed using Roche Friabilator .

10. Brands of PCM W1 (gm.) W2(gm.) % Friability Paracip 0.582 0.581 0.17% Dolo 0.599 0.597 0.33% Calpol 0.612 0.610 0.33% Crocin 0.584 0.583 0.17%

11. 3. Disintegration Test The result of disintegration test shows that all 4 different brands of PCM time for uncoated tablet. The brand disintegration time is less than 6 minutes which is less than the standard tion time is 37 sec. eans it disintegrate very fast so the drug will be available very to absorption and onset of time will be less. Brands of PCM Disintegration time(min.) Paracip 4.5 Dolo 5.5 Calpol 0.37 Crocin 3.5

12. 4. Dissolution Test The result of dissolution study shows that 4 brands release about 100% drug within one hour. The brand A and D releases about 80% drug within 5 minutes which means onset of action will be fast in these brands. The data proves that dissolution study of paracetamol complies pharacopoeial standards. Brands Weight (gm.) Absorbance (AU) Paracip 0.582 0.373 Dolo 0.599 0.780 Calpol 0.612 0.627 Crocin 0.584 0.739

13. 5. Drug Assay and HPLC testing The result shows that amount of PCM drug available is near to 100% means drug available as per stated value and dosage form is in stable form. In the HPLC testing, the chromatogram obtained with with the test solution, the area of any peak corresponding to 4- aminophenol is not greater than the area of peak in the chromatogram obtained with the reference solution. In the chromatogram obtained with the test solution peak with long retention time. Fig 9 = A modern self contained HPLC .

14. CONCLUSION The quality control evaluation of 4 different brands of PCM tablets those are available in pharmaceutical market were assessed by this study the values were compared with standards . On the basis of above observation, measured sample solution at 243 nm. UV- Spectrophotometer the concentration of Paracetamol . Calculated the content of paracetamol was not less than 80% of the standard amount of Paracetamol . The observed percentage is indicated that the Paracetamol is within the limit of Indian pharmacopeia . This shows that all 4 brands of PCM tablets meet the pharmacopoeial specification of different parameters. The results of various quality control parameters for tablets like weight variation, friability, disintegration time, drug assay and dissolution study, HPLC testing all are in the pharmacopoeial limits.

15. THANK YOU