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RESEARCH ARTICLE Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462 Department of Pharmaceutics ISSN (online) 2347-2154 International Journal of Innovative Pharmaceutical Sciences and Research www.ijipsr.com QUALITY ANALYSIS OF DIFFERENT BRANDS OF ACETAMINOPHEN AVAILABLE IN MARKET 1 Asma Eraj, 1Maria Ayub* Jinnah University for Women,Karachi 74600, Pakistan Abstract Acetaminophen has pronounced antipyretic and analgesics activity. Paracetamol is commonly used for treating certain mild to moderate pain, including that caused by flu, sprains, cold, headaches, dysmenorrhea, toothaches and minor arthritis pain. The present study was conducted to analyze, compare and evaluate the quality standards of commercially available brands of Acetaminophen (paracetamol) tablets include Panadol, Calpol and Febrol availaible in Pakistan as prescribed by B.P. & U.S.P. The quality control testing is an important factor of GMP (good manufacturing practices).The formulation of paracetamol is manufactured by different Multinational and national companies by using different manufacturing process as well as well as exciepients. The three different brands of paracetamol tablets (500mg) were evaluated comparatively for their physical parameters. The in-vitro test of all three brands of paracetamol include disintegration, hardness, friability and weight variation were found to be varying for each tablet, but within the specified limits. . The result was analyze by using spss 19.0 version applying one way ANOVA shows significant result between all three brand i.e. panadol, calpol and febrol. Its mean the value of p > 0.05 (C.I. 95 %) . Therefore it can be concluded that all three brand avilaible in Karachi meet the USP specification in quality control analysis. Keywords: Paracetamol, weight variation, Disintegration, Hardness, Friability. Corresponding Author: Maria Ayub Lecturer, Faculty of Pharmacy, Jinnah University for Women, Karachi 74600, PAKISTAN E-mail: [email protected]. Mobile: +92331-3119160 Available online: www.ijipsr.com October Issue 1457 RESEARCH ARTICLE Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462 Department of Pharmaceutics ISSN (online) 2347-2154 INTRODUCTION Acetaminophen commonly known as paracetamol, belonging to non-steroidal anti-inflammatory drugs (NSAIDs), widely used over the counter medicine [3].Chemically, it is 4-hydroxy acetanilide, its structure shown in Figure 1. [1] .Paracetamol is approved for reducing fever in people of all ages [2]. It is commonly prescribe for the anti-pyretic agent, analgesics, headaches, other minor aches and pains, and is a major ingredient in numerous cold and flu remedies [2]. It is effective and safe for human consumption at the recommended doses [5]. The main objective of an oral tablet is to deliver the drug to the human body at certain and defined amount through the gastro-intestinal system for producing therapeutic effect [6]. The drug product formulation can have a significant effect on the quality control parameters such as weight variation, hardness, friability, disintegration time, dissolution test etc. This also includes the physiochemical properties of the active ingredients and excipients as well as the procedures used in the manufacturing process [9]. The parameters which we include in our study are weight variation, hardness, friability and disintegration. Disintegration is the break down process of tablet into smaller particles and is the first step towards dissolution. Hadness effect disintegration of tablets. It depend upon the presence of disintegrate [10]. The hardness of tablet, binder, lubricant effect the disintegration time [10]. Faster disintegration of tablets delivers a fine suspension of drug particles resulting in a higher surface area and faster dissolution [3]. The weight variation, hardness, friability and disintegration time are important factor for good manufacturing practice (GMP [5]. In 2012, a comparative In-vitro analysis of different brands of paracetamol in Pakistan was evaluated for their physical, chemical parameters. In-vitro test like disintegration, friability, hardness, dissolution was perform & found to be verifying for each tablet but within the specified limit [7]. In 2012, a in-vitro comparative valuation of quality control paracetamol/caffien tablets available in bangladesh and conclude that the standard quality control parameter always should be maintenaid not only for paracetamol or its combination but also for all kinds of medicine for getting better drug product [8] . In 2012, comparative study of four different brands of acetaminophen was also conducted and concluded that all four brand varying with each other but they all comply within the limit [11]. The present study is designed to evaluate the in-vitro comparative study of three different brand of Paracetamol which include Panadol, Calpol and Febrol having same strength of 500 mg. for invitro study the disintegration test is selected . disintegration test was used to determine the time required for tablet to disintegrate. Available online: www.ijipsr.com October Issue 1458 RESEARCH ARTICLE Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462 Department of Pharmaceutics ISSN (online) 2347-2154 Figure 1: chemical structure of Paracetamol MATERIALS AND METHODS We have purchased different brands of Paracetamol (USP) of 500 mg from the local market i.e. Panadol, Calpol and Febrol. Different quality control testing was performed to compare all three brands with each other. Weight variation and average weight: Six tablets were selected from each of the brand and weighed individually using Electronic Balance FX-400. Note down the weight of each tablet on sheet in mg. Calculate average weight in mg. Hardness: There is no official limit specified in USP, BP or any other Pharmacopeia. Hardness or crushing strength were checked on 6 tablets of each brand using Hardness Tester MH-1,Galveno Scientific. Place tablets one by one and when the device was started, gradually applied force onto the tablet until it split, and the force at which the tablet split was recorded in Newton. Disintegration test: The standard disintegration time for USP uncoated tablet must be as low as 5 minutes but majority of the tablets have a maximum disintegration time of 30 minutes [13].The method specified in the USP/NF (1980) was used Disintegration Tester- USP, Electro lab: ED- 2L). The volume of disintegration medium used was 100ml of water and the temperature was maintained at 37±1°C throughout the experiment for each tablet of all the brands. Six tablets of each brand were selected and placed in each of the cylindrical tubes of the basket and the disc was used. The time taken to break each tablet into small particles and pass out through the mesh was recorded [12]. Friability: Ten tablets for each brand were initially weighed and transferred into Friabilator FB-400 one by one. The friabilator was operated at 25 rpm for 4 minutes (up to 100 revolutions). The tablets Available online: www.ijipsr.com October Issue 1459 RESEARCH ARTICLE Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462 Department of Pharmaceutics ISSN (online) 2347-2154 were weighed again and the calculate the friability in %. NMT 1% is the official limit. % Friability=Initial Weight(IW) - Final Weight(FW) / Initial Weight(IW) . RESULT AND DISCUSSION: Table 1: Parameters of three brands of Paracetamaol S.no 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 BRAND Disintegration PANADOL 126 120 120 132 138 131 CALPOL 84 81 79 85 78 80 FEBROL 21 20 20 23 25 22 Hardness 131 130 132 133 130 115 90 85 87 86 89 85 102 100 101 97 95 98 Weight variation 583 601 580 600 595 610 610 600 602 605 604 601 571 575 579 580 573 572 Friability 0.4 0.4 0.4 0.4 0.4 0.4 0.45 0.45 0.45 0.45 0.45 0.45 0.29 0.29 0.29 0.29 0.29 0.29 We conduct the comparative study of three different brand of paracetamol namely Panadol, Calpol and Febrol.. After testing selective parameters it was check for missing values and inconsistence. Data was analyzed in statistical package for social science (Spss) version 19.The frequency of sample is six. It was checked for Quality and Validity. Appropriate Statistical analysis, frequency and percentage were used, while one way ANOVA test was use to observe the comparative analysis between all these brands with each other. The physicochemical parameters of different brand of paracetamol tablet 500mg were analyzed. The result of weight variation, friability, hardness and disintegration were shown in Table-1 and Figure 2. The According to USP requirement of weight variation not more than 2 tablets. Different in weight between three brands is due to non-uniformity, uniformity serve as an indication to amount of active pharmaceutical Available online: www.ijipsr.com October Issue 1460 RESEARCH ARTICLE Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462 Department of Pharmaceutics ISSN (online) 2347-2154 ingredient i.e. paracetamol enclosed in the formulation as well as Good manufacturing practices (GMP).The hardness and disintegration time of all three brand were different with each other but met USP specification. According to USP it should be not more than 30 min. Disintegration time of Febrol is less as compare to calpol and panadol . The friability of all three brands of paracetamol tablet vary with each other but within specified limit i.e. NMT 1%. The results of selected brand are vary with each other but within specified USP limit. Using spss 19.0 version applying one way Anova shows significant result between all three brand i.e. panadol, calpol and febrol. Its mean the value of p > 0.05 (C.I. 95 %). Figure 2: Comparative study of three different brands CONCLUSIONS It is concluded that the results of all the tests (weight variation, disintegration ,hardness, Friability) of selected brands of Paracetamol tablet (500mg) exhibit some differences, but these variations are within the specified limits. REFERENCES 1. Amit KN.; 2010: Comparative in vitro dissolution assessment of some commercially available paracetamol tablets. International Journal of Pharmaceutical Sciences Review and Research ; 2(1): 29-30. Available online: www.ijipsr.com October Issue 1461 RESEARCH ARTICLE Maria Ayub et.al / IJIPSR / 3 (10), 2015, 1457-1462 Department of Pharmaceutics ISSN (online) 2347-2154 2. Aoshima, H., Miyagisniam, A., Nozawa,Y., Sadzuka, Y., Sonobe, T.,; 2005: Glycerin a.fatty acid esters as a new lubricant of tablets. Int. J. Pharm, 293, 25 – 34. 3. Fiebich, B.L., Lieb, K., Hull, M., Aicher, B., Ryn, J.V., Pairet, M., Engelhardt, G: 2000: Effects of caffeine and paracetamol alone or in combination with acetylsalicylic acid on prostaglandin E2 synthesis in rat microglial cells. Neuropharmacology, 39(11): 22052213. 4. Shibata, D., Shimada, Y., Yonezawa, Y., Sunada, H., Otomo, N., Kasahara, K., 2002: Application and evaluation of sucrose fatty acid esters as lubricants in the a.production of pharmaceuticals. J. Pharm. Sci. Technol., Jpn., , 62, 133 – 145. 5. Saxena Vaibhav, Khinchi Mahaveer P.R., Gupta M K.; 2010: International Journal of Research in Ayurveda & Pharmacy. 1(2): 399-407. 6. Islam, S.M.A., Islam, S., Shahriar, M., Dewan , I.; 2011:. Comparative in vitro dissolution study of aceclofenac marketed tablets in two different dissolution media by validated analytical method. Journal of Applied Pharma-ceutical Science, 1(9): 87-92. 7. Imran, Muhammad; ul Hassana, Najm; khana, M. Shifa; et al: 2011: Comparative in-vitro analysis of different available brands of paracetamol in Pakistan; Journal of Pharmacy Research;Dec2011, Vol. 4 Issue 12, p4399 8. Palash Karmakar, Md. Golam Kibria:2012 : In-vitro comparative evaluation of quality control parameters between paracetamol and paracetamol/caffeine tablets available in Bangladesh International Current Pharmaceutical Journal, 1(5): 103-109 9. Ofori-Kwakye, K., Osei-Yeboah, F., Kipo, S.L.; 2010: Formulation and quality evaluation of two conventional release tablet formulations. International Journal of Pharmaceutical Sciences Review and Research, 4(1): 94-99. 10. Remington, 2006: The science and practice of pharmaceutics :Edition : 21 st; v;1; 674. 11. Huma dilshad, Dr. Safila: 2014: Comparative study of four different brands of acetaminophen available in Karachi: World J Pharm Sci ; 2(6): 586-590. 12. Gangwar, S., Singh, S., Garg, G., Garg, V., Sharma, P.K. :2010: To compare the disintegrating property of papaya starch and sago starch in paracetamol tablets. Int J Pharmacy Pharm Sci, 2(Suppl 2): 148-151. 13. Banker, G.S. and Anderson, N.R. :2009:. Tablets. In Lachman, L. and Lieberman, H.A, The theory and practice of indus-trial pharmacy (Special Indian ed., pp 229-345), CBS Publishers and Distributors Pvt. Ltd., India Available online: www.ijipsr.com October Issue 1462