invitro and kinetic evaluation of several brands of clopidogrel 75 mg

  • Hira Akhtar Nazeer Hussain university
  • Khawaja Zafar Ahmed Professor of Pharmacology in SBB Deewan University Karachi, Pakistan
  • Hafsa Batool Final Year Student of Pharm D, Nazeer Hussain University, Karachi, Pakistan
  • Aqsa Sheikh Final Year Student of Pharm D, Nazeer Hussain University, Karachi, Pakistan
  • Warda Rafique Final Year Student of Pharm D, Nazeer Hussain University, Karachi, Pakistan
  • Nisha Mansoor Final Year Student of Pharm D, Nazeer Hussain University, Karachi, Pakistan
Keywords: Invitro, kinetics approaches, model dependent, comparison


Objective: The main objective of this study is to perform the invitro quality assessment of ten different marketed brands of Clopidogrel (75mg) available in the Karachi, Pakistan.

Methodology: Pharmacopoeial and non pharmacopoeial test have been performed on all ten selected brands of Clopidogrel coded as C1, C2, C3…C10. A sample of 10 tablets from each brand were subjects to performed pharmacopoeial test such as weight variation, friability, disintegration, assay and dissolution. Non pharmacopoeial test include hardness, thickness and diameter. All the dissolution data were subjected to model dependent and model independent kinetics approaches.

Result:  The average weight variation of all ten coded brands of Clopidogrel were found to be 225.9-356.1 mg, followed the USP specification of ±7.5% deviation. After performing hardness, thickness and diameter of all selected tablets, the values were found to be in specified limited given by USP. The disintegration time of all test formulation was 2-8minutes, which meet the USP standard disintegration limit of film coated tablets. % friability of tested tablets was found to be 0.02-0.3%, which lies in the standard limit of % friability of bearing enough mechanical strength. In this study assay studies of Clopidogrel was found to be in the range of 98.7% to 101.30%, which lying under the limits of USP assay monograph. The dissolution test was subjected to model dependent and model independent kinetics approaches by using Dissolution Data solver (DD solver). 0.1N HCl were used for multiple point dissolution studies, range of 90.9%-99.8% drug released was analyzed on UV spectrophotometer at the wavelength of 270nm which also found to be in USP specifications. The fundamental measures of similarity factor (f1) and dissimilarity factor (f2) values were also found to be in limits. After applying all the kinetics models on coded brands of Clopidogrel, the calculated r2 value followed all model kinetics approaches.

Conclusion: In this successful study, application of pharmacopoeial and non pharmacopoeial test on ten different coded brands of Clopidogrel (75mg) available in Karachi, Pakistan. Further work is recommended on large scale sample. All the values were found to be in limits and meets the specifications given by the United State Pharmacopeia. Moreover, invitro multiple point dissolution studies were carried out by the application of Dissolution Data solver (DD solver) and were subjected to all kinetics models.



Galata DL, Zsiros B, Mészáros LA, Nagy B, Szabó E,

Farkas A, Nagy ZK. Raman mapping-based nondestructive dissolution prediction of sustained-release

tablets. J Pharm Biomed Anal. 2022 Apr 1;212:114661

Prabu SL, Suriyaprakash T, Thirumurugan R,

Shanmugarathinam AJPT. Process validation: A review.

Pharma times 2014;46(4):12-5.

Bhavana P, Reddy MSJGB, Sciences P. A review on

co-processed excipients used in direct compression of

tablet dosage form. Bio and Pharma Sci. 2023;23(1):212-

Rao KR, Lakshmi KR. Design, development and

evaluation of clopidogrel bisulfate floating tablets. Int

J Pharm Investig. 2014;4(1):19-26.

Lo ST, Li RHL, Georges CJ, Nguyen N, Chen CK,

Stuhlmann C, Synergistic inhibitory effects of

clopidogrel and rivaroxaban on platelet function and

platelet-dependent thrombin generation in cats. J Vet

Intern Med. 2023;37(4):1390-1400

Abdul-hasan MT, Al-shaibani AJ, Wannas AN, Hasan

al-gburi KM. Quality control testing of conventional

clopidogrel bisulfate tablets marketed in Iraq. Int J App

Pharm. 2022 7;14(1):221-5.

Al-Saikhan F, Ahmad N, Abd-Elaziz M, Iqbal MS.

Adverse Effects of Clopidogrel: a Cross Sectional Study

of the FDA Adverse Event Reporting System Database.

Lat. Am. J. Pharm. 2022;41(7):1388-91.

Iqubal MK, Singh P, Shuaib M, Iqubal A, Singh MJ,

Devel. Recent advances in direct compression technique

for pharmaceutical tablet formulation. Int J of Pharma

Res and Dev.2014 ;6(1):49-57.

Gunda RK, Kumar JN. Formulation development and

evaluation of amisulpride fast dissolving tablets. J.Pharm.

Sci 2018;43(2):105-16.

Dasari T, Kala SLJ, Nadendla RR. In process quality

control tests of solid dosage forms: a comprehensive

review. sch Acad J of Pharm 2017;6(8):334-45.

Ann Jinnah Sindh Med Uni 2023; 9(2):49-55 54

Hira Akhtar, Khawaja Zafar Ahmed, Hafsa Batool, Aqsa Sheikh, Warda Rafique, Nisha Mansoor

Osei-Yeboah F, Sun CC. Validation and applications of

an expedited tablet friability method. Int J Pharm.


Markl D, Zeitler JA. A Review of Disintegration

Mechanisms and Measurement Techniques. Pharm Res.


Kumar D, Singh J, Antil M, Kumar VJ, Sciences B.

Quality control of tablets: a review. Int. J of Uni Pharm

and Bio sci 2016;5(4):53-167.

Mahammed N, Yadav H, Thulluru A, Narayana N,

Saravanakumar A, Balaji S, et al. Formulation and

evaluation of clopidogrel bisulphate tablets by liquisolid

compact technique. Res J Pharm & Technol.


Silvia F, Marina Marcos V, Octavio F, Norma S, Sonia

F. Comparative dissolution and polymorphism study of

clopidogrel bisulfate tablets available in Argentine. J

App Pharm Sci. 2020;10(10):062-72.

Lalitha LJ, Chenthilnathan A, Vidyasagar VJ. Process

validation of clopidogrel bisulphate 75 mg tablets. Sch

Res Lib. 2014;6(3):72-8.

Tarawneh OA, Madi AM, Hamed R, Qirem R, Qerem

W, Alhusban A, et al. In vitro Characterization and

Evaluation of Commercialized Paracetamol Products

in Jordan. Dissolution Technol. 2019;26(1):36-44

Convention USP, Editor nThe Pharmacopoeia of the

United States of America 1916: United States

Pharmacopoeial Convention, Incorporated 2018.

Sidra Urooj, Rizwana I. Review article on

pharmaceutical analysis of tablets according to standard

pharmacopeias. J Emerg Tech & IR. 2021;8(9):474-84.

Barsagade P, Khetade R, Nirwan K, Agrawal T, Gotafode

S, Lade U. Using RP-HPLC. Int. J of Pharma Sci Review

and Res 2021;05:28-38.

Wojcik-Pastuszka D, Krzak J, Macikowski B, Berkowski

R, Osiñski B, Musia³ W. Evaluation of the Release

Kinetics of a Pharmacologically Active Substance from

Model Intra-Articular Implants Replacing the Cruciate

Ligaments of the Knee. Materials (Basel). 2019; 12(8):

Laracuente ML, Yu MH, McHugh KJ. Zero-order drug

delivery: State of the art and future prospects. J Control

Release. 2020;327:834-856

Jain A, Jain SK. In vitro release kinetics model fitting

of liposomes: an insight. Chem Phys Lipids. 2016:


Drucker CT, Senger LW, Pacioles CT. Application of

the weibull model to describe the kinetic behaviors of

thiol decolorizers in chlorogenic acid-lysine solutions.

J Food Eng. 2023;339:111287.

How to Cite
Akhtar, H., Ahmed, K., Batool, H., Sheikh, A., Rafique, W., & Mansoor, N. (2023). INVITRO ASSESSMENT AND APPLICATION OF KINETICS MODELS ON DISSOLUTION PROFILE OF SEVERAL BRANDS OF CLOPIDOGREL (75MG) AVAILABLE IN KARACHI, PAKISTAN. Annals of Jinnah Sindh Medical University, 9(2), 49-55. Retrieved from
Original Articles