Comparative Evaluation of Some Commercial Clopidogrel Tablets Available in Yemen

https://doi.org/10.22146/farmaseutik.v13i2.40917

Bassam Abduh Ali(1*), Mohammed Gameel Al-haddad(2), Abdullah Ahmed Areqi(3)

(1) Department of Pharmaceutics, Faculty of Pharmacy, University of Science and Technology, Taiz Branch, Yemen
(2) Department of Pharmaceutics, Faculty of Pharmacy, University of Science and Technology, Hodaidah Branch, Yemen
(3) Department of Pharmacology, Faculty of Pharmacy, University of Science and Technology, Hodiadah, Yemen
(*) Corresponding Author

Abstract


Clopidogrel is a medication to reduce the risk of heart disease and taken orally. Quality of drug characterizes the production process and every phamaceutical company strives for it but often it is very difficult to achieve. This study was to investigate quality control parameters of some marketed Clopidogrel tablets. To assess the quality, eight different marketed brands of Clopidogrel 75 mg tablets available in Yemeni market collected from different pharmacies in Hodeida city. Different quality parameters like weight variation, hardness, thickness and friability were determined according to established protocols. Then the in-vitro dissolution test, potency, disintegration time were also carried out. UV-spectrophotometer was used to determine the percentage released and assay at 218 nm. All the brands comply the requirements of Pharmacopoeia as they showed acceptable weight variation range. Friability of all brands was less than 1% and no significant differences in disintegration times as they disintegrated within 15 minutes. In case of dissolution profile, all brands except C6 showed acceptable dissolution time as they released more than 60% of drug in 45 minute. The hardness of only two brands was within the range. All brands also meet the potency specifications. This study suggested that most commercially Clopidogrel tablets in Yemen maintain the quality and comply with the pharmacopeia specifications.

Keywords


Clopidogrel, Physicochemical, Dissolution profile, Potency.

Full Text:

PDF


References

Abdel Naser Zaid., Rowa’ Al Ramahi., Rana Bustami and Ayman Mousa., (2015), Comparative fasting bioavailability of two clopidogrel formulations in healthy Mediterranean volunteers: an in vitro–in vivo correlation, Drug Design, Development and Therapy,9 ,2359–2365.

Anderson., G. S. Tablets. In L. Lachman., H. A. Lieberman., & J. Kanig., (2009) The theory and practice of industrial pharmacy. Bombay: Varghese publishing house. (pp. 293-345).

Cazedey., E. C. L., & Salgado., H. R. N. (2012). Spectrophotometric determination of ciprofloxacin hydrochloride in ophthalmic solution. Advances in Analytical Chemistry, 2(6), 74-79. Chouhan, A., Marothia, D., Ranka, K., & Rathore, K. S. (2016). Formulation and Evaluation of Extended Release Tablets of Metformin HCl.

Gibson, (2001), Pharmaceutical preformulation and formulation. HIS Health group, Englewood.

Gomez, Y., Adams, E., & Hoogmartens, J. (2004). Analysis of purity in 19 drug product tablets containing clopidogrel: 18 copies versus the original brand. Journal of pharmaceutical and biomedical analysis, 34(2), 341-348.

Griffin, R.(2012). Management. New York: Houghton Mifflin Company.

Gunda, R. K. (2015). Formulation development and evaluation of rosiglitazone maleate sustained release tablets using 32 factorial design. IJPTR, 8, 713-24.

Gupta KA (2010) Introduction to Pharmaceutics-I. Cbs Publishers & Distributors, New Delhi (India), Pp: 344-398.

Hasan A., Dewan SAR., Ahamed SK., Kai MM (2013) Quality control studies on cetirizine hydrochloride tablets available in Bangladesh drug market. International Journal of Pharmacy and Biological Sciences 3(1): 349-354.

Kamal, S. (2012). Evaluation of Quality Control Parameters of Two Brands of Diazepam Tablets (Doctoral dissertation, East West University).

Kanij ND1., Lovely Z1., Abdul A1., Sanjida H2., Sabrin IK3 and Sharmeen A4 (2017), Comparative In Vitro Quality

MF Vol 13 No 2, 2017 87

Evaluation of Some Clopidogrel Tablets, Commercially Available in Bangladesh Drug Market. Bioequiv & Bioavailab Int J 1(3): 000117.

Karch, A. M. (2014). Lippincott's nursing

drug guide. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins.

Kishore N., Singh A., Reddy N (2013) Formulation and Evaluavation of Clopidogrel Bisulfate Immediate Release Tablets. International Journal of Life Sciences 1(1): 11-18.

Kumar K., Vijayakumar K., Reddy N (2013) Clopidogrel an Overview. International journal of Pharmacology science 3(1): 1-7.

Lamba, S. S.(2010), Pharmaceutical Facilities New Concept in Facility Design. Eisai (pp. 1-28). Monographs, O. (2002). United States Pharmacopeia-National Formulary (USP 25-NF 20). Rockville, Maryland: United States Pharmacopeial Convention Inc.

Nasrin N., Asaduzzaman M., Mowla R., Rizwan F., Alam A (2011) A comparative study of physical parameters of selected ketorolac tromethamine tablets available in the pharma market of Bangladesh. Journal of applied phramceutical Sciences 1(8): 101-103.

Nushrat SA., Nasreen W., Deepa KN (2017) In vitro comparative study of quality control parameter of some brand of ketorolac tablets available in Bangladesh. World journal of pharmacy and pharmaceutical science 6(8): 146-155.

Rao, K. R. K., & Lakshmi, K. R. (2014). Design, development and evaluation of clopidogrel bisulfate floating tablets. International Journal of Pharmaceutical Investigation, 4(1), 19–26.

Suhas Gurav., Rohan Tembare., Vishali Salunkhe., Devprakash, Senthilkumar G.P.(2011), Spectrophotometric determination of clopidogrel bisulfate in pharmaceutical formulations. American Journal of

PharmTech Research. 1(4): 258-263. United State Pharmacopeia ) USP) (2004) 27 United State Convention : pp. 2622-2625. United States Drug Enforcement Administration. (2016) Benzodiazepinesarticle available at http: //www.justice.gov/dea / concer n/benzodiazepines.

Yarkala S., Sivakumar A., Sameer G., (2012), Physico-Chemical Studies on Stability of Clopidogrel Tablet Formulations. International Journal of Pharmaceutical and Biological Science 3(4): 433-439.



DOI: https://doi.org/10.22146/farmaseutik.v13i2.40917

Article Metrics

Abstract views : 4992 | views : 2700

Refbacks

  • There are currently no refbacks.


Majalah Farmaseutik Indexed by:

   
 
Creative Commons Licence
 
 
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.