Titrimetric and Spectrophotometric Assay of Pantoprazole in Pharmaceuticals Using Permanganate


  • Kanakapura Basavaiah University of Mysore
  • Nagaraju Rajendraprasad University of Mysore
  • Kalsang Tharpa University of Mysore
  • Urdigere Rangachar Anilkumar University of Mysore
  • Salamara Ganeshbhat Hiriyanna Advinus Therapeutics
  • Kanakapura Basavaiah Vinay Advinus Therapeutics




Pantoprazole, assay, titrimetry, spectrophotometry, permanganate, pharmaceuticals


Titrimetric and spectrophotometric assay of pantoprazole sodium (PPS) using permanganate as the oxidimetric reagent is described. In titrimetry, PPS is treated with a measured excess of permanganate in H2SO4 medium followed by the determination of unreacted oxidant by back titrating with a standard iron(II) solution. Spectrophotometry involves addition of a known excess of permanganate to PPS in H2SO4 medium followed by the measurement of absorbance of the residual permanganate at 545 nm. In both the methods, the amount of permanganate reacted corresponds to the PPS content. Experimental conditions that provide wide linear range, maximum sensitivity and selectivity, and accuracy and precisions have been optimized. In titrimetry, the calculations are based on a 1:1 (PPS : KMnO4) reaction stoichiometry and the method is applicable over 1.0-7.0 mg range. In spectrophotometry, Beer’s law is obeyed over the concentration range 15.0-150.0 µg mL-1. The linear regression equation of the calibration graph is A = 0.78 + 0.005 C with a regression coefficient (r) of 0.9982 (n = 11). The apparent molar absorptivity is calculated to be 2.213 × 103 l mol-1cm-1 and the Sandell sensitivity is 0.1954 µg cm-2. The limits of detection (LOD) and quantification (LOQ) calculated as per the ICH guidelines are 0.73 and 2.21 µg mL-1, respectively. Accuracy and precision of the assays were determined by computing the intra-day and inter-day variations at three different levels of PPS; the intra-day and inter-day RSD was < 3.09 % and the accuracy was better than 3.5 %. The methods were successfully applied to the determination of PPS in three different brands of tablets with good accuracy and precision, and without detectable interference by excipients. The accuracy was further ascertained by placebo blank and synthetic mixture analyses and also by recovery experiments via standard-addition procedure.


Download data is not yet available.

Author Biographies

Kanakapura Basavaiah, University of Mysore

Department of Chemistry

Nagaraju Rajendraprasad, University of Mysore

Department of Chemistry

Kalsang Tharpa, University of Mysore

Department of Chemistry

Urdigere Rangachar Anilkumar, University of Mysore

Department of Chemistry

Salamara Ganeshbhat Hiriyanna, Advinus Therapeutics

Process Analytical Laboratory

Kanakapura Basavaiah Vinay, Advinus Therapeutics

Process Analytical Laboratory


1. Budavari, S., Ed., The Merck Index, 12th Edition, New Jersey, 1996, 1205.
2. Mansour, A. M.; Sorour, O. M. Chromatographia Supplement 2001, 53, S478-S479.
3. Patel, B. H.; Suhagia, B. N.; Patel, M. M.; Patel, J. R. Chromatographia 2007, 65,743-748.
4. Xue-Hui, H.; Fu- Sheng, P. Zhongguo Yiyao Gongye Zazhi 2000, 31, 502-503.
5. Basavaiah, K.; Anilkumar, U. R.; Tharpa, K. Int. J. Chem. Sci. 2008, 6, 579-586.
6. Agbaba, D.; Novovic, D.; Karljikovic-Rajic, K.; Marinkovic, V. J. Planar Chromatogr. Modern TLC. 2004, 17, 169-172.
7. Karljikovic-Rajic, K.; Novovic, D.; Marinkovic, D.; Agbaba, D. J. Pharm. Biomed. Anal. 2003, 32, 1019-1027.
8. Wahbi, A. M.; Abdel-Razak, O.; Gazy, A. A.; Mahgoub, H.; Moneeb, M. S. J. Pharm. Biomed. Anal. 2002, 30, 1133-1142.
9. Salama, F.; El-Abasawy, N.; Razeq, S. A. A.; Ismail, M. F.; Fouad, M. M. Bull. Fac. Pharm. (Cairo Univ) 2003, 41, 185-196.
10. Salama, F.; El-Abasawy, N.; Razeq, S. A. A.; Ismail, M. F.; Fouad, M. M. J. Pharm. Biomed. Anal. 2003, 33, 411-421.
11. Moustafa, A. A. M. J. Pharm. Biomed. Anal. 2000, 22, 45-48.
12. Basavaiah, K.; Anilkumar, U. R. Indian J. Chem. Technol. 2007, 14, 611-615.
13. Basavaiah, K.; Anilkumar, U. R. Bulg. Chem. Commun. 2007, 39, 159-164.
14. Basavaiah, K.; Anilkumar, U. R. Bull. Chem. Soc. Ethiop. 2008, 22, 135-141.
15. International Conference On Hormonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology dated 06 November 1996, incorporated in November 2005, London.
16. Ashworth, MRF. Titrimetric Organic Analysis. Part-I: Direct Methods, Interscience Publications, John-Wiley & Sons, New York, 1964, 368-374
17. Kolthoff, I. M.; Belchov, R. Volumetric Analysis. Vol. III, Interscience Publications. Inc., New York, 1957, 33-119.
18. Tammilehto, S. A. J. Pharm. Pharmacol. 1980, 32, 524.
19. Murugesan, A.; Venkappayya, D. Curr. Sci. 1983, 52, 249.
20. Kucharski, M.; Sikorska-Tomicka, H. Chem. Anal (Warsaw). 1982, 27, 491.
21. Fedchenko, S. B. Farmatsiya (Moscow). 1985, 34, 65.
22. Stepnayuk, S. N.; Balagorazumnya, N. V. Farmatsiya (Moscow). 1989, 38, 67.
23. Suganthi, A.; Shivakumar, H. B.; Vijaykumar, S. C.; Ravimathi, P.; Ravi, T. K. Indian J. Pharm. Sci. 2006, 68, 373.
24. Al-Tamrah, S. A. Anal. Chim. Acta 1999, 379, 75.
25. Abdellatef, H. E. J. Pharm. Biomed. Anal. 2002, 29, 835.
26. Reddy, M. N.; Reddy, V. P. N.; Reddy, P. J. C.; Murthy, T. K.; Srinivasa Rao, Y. The Antiseptic 2002, 99, 88.
27. Al-Ghanman, S. M.; Belal, F. Farmaco 2001, 56, 677-681.
28. Sastry, C. S. P.; Vijaya, R. T.; Satyanarayana, A. Indian. J. Pharma. Sci, 1998, 60, 55-58.
29. Vogel. A. I. Text-Book of Inorganic Analysis, Including Elementary Instrumental Analysis, Longsman, London, 1962, 280.






Regular Articles

Similar Articles

You may also start an advanced similarity search for this article.