Author(s):
Shweta Sinha, Jitendra Yadav, Dolly Dewangan, Kamraj, Krity Gupta, Manish Kumar Sahu, Parimal Verma, Prashant Kumar Sahu, Aakanksha Sinha, S. J. Daharwal
Email(s):
Email ID Not Available
DOI:
10.52711/2231-5675.2026.00003
Address:
Shweta Sinha*, Jitendra Yadav, Dolly Dewangan, Kamraj, Krity Gupta, Manish Kumar Sahu, Parimal Verma, Prashant Kumar Sahu, Aakanksha Sinha, S. J. Daharwal
University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G).
*Corresponding Author
Published In:
Volume - 16,
Issue - 1,
Year - 2026
ABSTRACT:
For the quantitative determination of clopidogrel bisulphate in bulk and pharmaceutical dose forms, a straightforward, accurate, precise, and economical approach has been established. Methanol (a co-solvent) and 0.05 N acetic acid (a solvent) were used to create the standard and sample solutions. Area Under Curve (AUC), Zero order, and First order derivative are the three UV spectrophotometric methods that were developed. The zero order technique showed linearity at 270 nm over 10–100µg/ml with R² = 0.9992. The first derivative methodology yielded R² = 0.9996 at 244nm and 281nm (R² = 0.9987), whereas the AUC method yielded R² = 0.9994 at 265–275nm. For criteria including linearity, accuracy, precision, LOD, and LOQ, all techniques were validated in accordance with ICH guidelines. Precision studies showed that the percentage relative standard deviation was within acceptable boundaries. The results confirmed that all of the suggested methods are simple, sensitive, accurate, and suitable for routine drug screening in pharmaceutical formulations.
Cite this article:
Shweta Sinha, Jitendra Yadav, Dolly Dewangan, Kamraj, Krity Gupta, Manish Kumar Sahu, Parimal Verma, Prashant Kumar Sahu, Aakanksha Sinha, S. J. Daharwal. Validation of the UV Spectrophotometric Method for the Quantitative measurement of Clopidogrel bisulphate in Pharmaceutical Dosage Form and Bulk. Asian Journal of Pharmaceutical Analysis. 2026; 16(1):14-0. doi: 10.52711/2231-5675.2026.00003
Cite(Electronic):
Shweta Sinha, Jitendra Yadav, Dolly Dewangan, Kamraj, Krity Gupta, Manish Kumar Sahu, Parimal Verma, Prashant Kumar Sahu, Aakanksha Sinha, S. J. Daharwal. Validation of the UV Spectrophotometric Method for the Quantitative measurement of Clopidogrel bisulphate in Pharmaceutical Dosage Form and Bulk. Asian Journal of Pharmaceutical Analysis. 2026; 16(1):14-0. doi: 10.52711/2231-5675.2026.00003 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-1-3
REFERANCE:
1. Kumbhar AC, Gherade PB, Sonkamble SS, Pawar KR. A review of analytical methods for clopidogrel bisulfate. Asian Journal of Pharmaceutical Analysis. 2024; 14(4): 266-74.
2. Mohamed SH, Issa YM, Salim AI. Quantitative Determination of Clopidogrel Bisulfate using Validated Spectrophotometric Methods. Asian Journal of Advances in Research. 2020; 4(1): 14-24.
3. Rao KR, Lakshmi KR. Design, development and evaluation of clopidogrel bisulfate floating tablets. International Journal of Pharmaceutical Investigation. 2014 Jan;4(1):19.
4. Kim YI, Kim KS, Suh KH, Shanmugam S, Woo JS, Yong CS, Choi HG. New clopidogrel napadisilate salt and its solid dispersion with improved stability and bioequivalence to the commercial clopidogrel bisulphate salt in beagle dogs. International Journal of Pharmaceutics. 2011 Aug 30; 415(1-2): 129-39.
5. Deshkar SS, Pawara AS, Shirolkar SV. Formulation and optimization of floating tablets of clopidogrel bisulfate using design of experiments. Int. J. Appl. Pharm. 2018; 10(6): 94-102.
6. Deevan Paul A, Neelima A, Prasanthi C, Kota N. Method Development Technologies for Clopidogrel Bisulphate by Improving Solubility and Bioavailability. International journal of Applied Pharmaceutical Sciences and Research. 2021; 6(2): 15 – 21.
7. Beavers, C. J., Patel, P., and Naqvi, I. A. (2025). Clopidogrel. In StatPearls. StatPearls Publishing.
8. Lestari, M. L., Suciati, Indrayanto, G., and Brittain, H. G. Clopidogrel bisulfate. Profiles of drug substances, excipients, and related methodology. Science Direct. 2010; 35: 71–115. https://doi.org/10.1016/S1871-5125(10)35002-3.
9. Sahu R, Saxena S, Jain S. Increased the dissolution rate and solubility of clopidogrel bisulfate orodispersible tablets. Asian Journal of Pharmaceutical Education and Research. 2021 Mar; 10(1): 96 – 109.
10. Osmanović Omerdić E, Alagić-Džambić L, Krstić M, Pašić-Kulenović M, Odović J, Vasiljević D. In vitro dissolution study of acetylsalicylic acid and clopidogrel bisulfate solid dispersions: validation of the RP-HPLC method for simultaneous analysis. Applied Sciences. 2020 Jul 13; 10(14): 4792.
11. Zainab E. Jassim and Ahmed A. Hussein. Dissolution method development and enhancement of solubility of clopidogrel bisulfate. Int. Res. J. Pharm. 2017; 8(6): 25-29 http://dx.doi.org/ 10.7897/2230-8407.08691
12. Rajendra VB, Deshmukh OJ, Rawat PK, Gulecha BS, Khushwaha S, Ghadlinge SV. Spectrophotometric method for the estimation of Clopidogrel bisulphate residue in swab samples. World J. Pharm. Res. 2012 Jun 11; 1: 850-8.
13. Koçak ÖF, Kadıoğlu Y, Şenol O. Determination of Clopidogrel in Pharmaceutical Preparation by UV Spectrophotometry and High Performance Liquid Chromatography Methods. International Journal of Innovative Research and Reviews. 2020 Jul 15; 4(1): 14-9.
14. Rele RV. Development and validation of second order derivative methods for quantitative estimation of clopidogrel in bulk and pharmaceutical dosage form. Der Pharmacia Lettre. 2014; 6(6): 117-121.
15. KS K, RR H, Kaaviya AA, KS L. A Review of Analytical Methods for the determination of Clopidogrel in Pharmaceuticals and Biological Matrices. Critical Reviews in Analytical Chemistry. 2018 Mar 1; 48(2).
16. Cholke PB, Ahmed R, Chemate SZ, Jadhav KR. Development and Validation of Spectrophotometric Method for Clopidogrel bisulfate in pure and in film coated tablet dosage form. Arch. Appl. Sci. Res. 2012; 4(1): 59-64.
17. Game MD, Gabhane KB, Sakarkar DM. Quantitative analysis of clopidogrel bisulphate and aspirin by first derivative spectrophotometric method in tablets. Indian Journal of Pharmaceutical Sciences. 2010 Nov; 72(6): 825.
18. Dermiş S, Aydoğan E. Rapid and accurate determination of clopidogrel in tablets by using spectrophotometric and chromatographic techniques. Communications Faculty of Sciences University of Ankara Series B Chemistry and Chemical Engineering. 2009; 55(1): 1-6.