REDOX REACTION BASED SPECTROPHOTOMETRIC ASSAY OF SOME DRUGS IN PHARMACEUTICALS
Objectives: Pyridoxine hydrochloride (PRC) is used in the treatment of side roblastic anemiaâ€™s and is also used in a variety of disorders including the treatment of depression. Dobutamine Hydrochloride (DOB) is used in the case of congestive heart failure to increase cardiac output and is also commonly used in the hospital setting as a pharmacologic stress testing agent to identify coronary artery disease. Linezolid (LZD) is a synthetic antibiotic used for the treatment of serious infections caused by gram-positive bacteria that are resistant to several other antibiotics. The main objective of our method is to develop a simple, accurate and sensitive spectrophotometric method for the assay of the above mentioned drugs in both tablet and pharmaceutical dosage forms.
Methods: The method is based on the red ox reaction of drugs with Folin Ciocalteu (FC) reagent in sodium carbonate medium and the resulting blue colored chromogen is measured at 755 nm.
Results: Beerâ€™s law is obeyed in the concentration range of 2.5â€“30 Âµg/ml (PRC), 1â€“10 Âµg/ml (DOB) and 2.5â€“70 Âµg/ml (LZD) respectively, with the corresponding molar absorptivity values of 7.145 X 103, 3.2080 X 104 and 6.299 X 103 l mol-1 cm-1. The method is validated for accuracy, precision, LOD, LOQ, robustness and ruggedness as per the current ICH guidelines.
Conclusion: The validated method is successfully applied to quantify PRC, DOB and LZD in their commercial formulations with satisfactory results; hence the method is suitable for the determination of drugs in bulk and pharmaceuticals.
2. Otsing L, Fillet M, Bechet I, Hubert P, Crommen J. Determination of six water soluble vitamins in a pharmaceutical formulation by capillary electrophoresis. J Pharm Biomed Anal 1997;15:1113-23.
3. Dinc E, Baleanu D. A zero-crossing technique for the multi determination of thiamine HCl and Pyridoxine HCl in their mixture by using one-dimensional wavelength transform. J Pharm Biomed Anal 2003;3:969-78.
4. Abdulrahman A, Alwarthan Fatima A Aly. Chemiluminiscent determination of Pyridoxine Hydrochloride in pharmaceutical samples using flow injection. Talanta 1998;45:1131-8.
5. Gowekar NM, Madhekar MD, Nalawade CC, Jadhav KG, Dhanwade PP, Gowekar SN. Derivative spectrophotometric method for the estimation of Pyridoxine Hydrochloride in bulk drug and dosage form. Int J Pharm Chem Sci 2012;1:339-47.
6. Nevik Erk. Derivative ratio spectrophotometry and Differential derivative spectrophotometric determination of Isoniazid and pyridoxine hydrochloride in dosage forms. Spectrosc Lett 2001;34:745-61.
7. Pengfei Jin, Lufeng Xia, Zheng Li, Ning Che, Ding Zou, Xin Hu. Rapid determination of the Amine, Riboflavin, Niacinamide, Pantothenic acid, Pyridoxine, Folic acid and Ascorbic acid in vitamins with minerals tablets by HPLC with diode array detector. J Pharm Biomed Anal 2012;70:151-9.
8. Pengfei Jin, Jie Ma, Xuejun Wu, Ding Zou, Chunhua Sun, Xin Hu. Simultaneous determination of pharmaceutical eye drops by a ion-pair HPLC. J Pharm Biomed Anal 2009;5:293-7.
9. Ayman A, Gouda, Mohammed J, Kotb El-Sayed, Alaa S Amin, Ragaa El Sheikh. Spectrophotometric and Spectrofluorimetric methods for the determination of non-steroidal anti-inflammatory drugs. Arab J Chem 2013;6:145-63.
10. Mohammed-Hussain Sorouraddin, Mohammed-Reza Rashidi, Ibrahim Ghorbani-Kalhor, Karim Asad Pour-Zeynali. Simaltaneous spectrofluorimetric and spectrophotometric determination of melatonin and pyridoxine hydrochloride in pharmaceutical preparations by multivariate calibration methods. II Farmaco 2005;60:451-8.
11. Smitha C Nayak, Preeti V Kulkarni, Vaidhun Bhaskar, Vinit Chavhan. Development and validation of UV spectrophotometric method for simaltaneous estimation of Doxylamine succinate and pyridoxine hydrochloride in bulk and tablet dosage forms. Int J Pharm Pharm Sci 2013;5:390-3.
12. Sayeed M Arayne, Nazma Sultana, Farhan Ahmed Siddiqui, Hashim Zuberi, Agha Zeeshan Mirza. Spectrophotometric methods for the simultaneous analysis of meclezine hydrochloride and pyridoxine hydrochloride in bulk drug and pharmaceutical formulations. Pak J Pharm Sci 2007;20:149-56.
13. Alaa El-Gindy. Spectrophotometric and LC determination of two binary mixtures containing pyridoxine hydrochloride. J Pharm Biomed Anal 2003;32:277-86.
14. British Pharmacopoeia: Her majestyâ€™s stationary office. 1st ed. London; 2007.
15. Jin L, Jianhua L, Gulliang C. Capillary gas chromatographic determination of organic residual in Dobutamine hydrochloride using head space injection and direct injection of solution. Yaownfenxizazhi 2006;26:120-3.
16. Yan Z. Voltametric behavior of Dobutamine at polyâ€“Alcidine orange film modified electrode and its determination by adsorptive stripping voltametry. Anal Lett 2004;37:2031â€“42.
17. Yingxue Z, Funan C, Zhujan Z. Chemiluminescence determination of Dobutamine Hydrochloride in human serum by high performance liquid chromatographic separation connected with ultra filtration technology. Fenxihuaxue 2004;32:769-71.
18. Ramesh Thippani, Nageswara rao pothuraju, Nageshwara Rao Raminetti, Saida Shaik. Optimization and validation of a fast Reverse phase-high performance liquid chromatographic method for the determination of Dobutamine in rat plasma. J Pharm Anal 2013;3:434â€“9.
19. Michael E, El-Kommos. Spectrophotometric method for the determination of Dobutamine Hydrochloride. Analyst 1983;108:380-5.
20. Prashanthi M, Venkateshwaralu G. Pharmaceutical analysis using potassium permanganateâ€“Saffraninâ€“O dye couple: A spectrophotometric study. Asian J Biochem Pharm Res 2013;4:17â€“181.
21. Sayanna K, Venkateshwaralu G. Spectrophotometric determination of cardiovascular drugs. Int J Modern Eng Res 2013;3:3079â€“85.
22. British Pharmacopeia: Her majestyâ€™s stationary office. 6th ed. London; 2010. p. 410.
23. Michalska K, Pajchel G, Tyski S. Determination of Linezolid and its achiral impurities using sweeping pre concentration by micellar capillary electrophoresis. J Pharm Biomed Anal 2008;48:321-30.
24. Prashanthi JK, Sundar SB. A validated RP-HPLC method for the determination of Linezolid in pharmaceutical dosage forms. Int J Pharm Biol Sci 2012;3:44-51.
25. Mathrusri Annapurna M, Satish Kumar K, Sai Gangadhara Reddy. New Derivative spectrophotometric methods for the determination of Linezolid an antibacterial drug. J Chem Pharm Res 2012;4:714-8.
26. Prashanthi P, Mateti A, Vanitha P, Thimmaraju MK, Raghunandan N. Development and validation of UV spectrophotometric method for the estimation of Linezolid in bulk and pharmaceutical formulation. Int J Nat Prod Res 2012;2:57-60.
27. Mehul M Patel, Patel DP, Goswami K. Development and validation of UV spectrophotometric method for simultaneous estimation of Cefexime and Linezolid in combined dosage. Int J Pharm Res Scholars 2012;4:112-8.
28. Gadhiya Dolly Tulsibhai, Bagada Hina Laxmanbhai. Spectrophotometric method development and validation for estimation of Linezolid in tablet dosage form. Res Pharm 2013;3:6-12.
29. ICH Steering Committee: ICH harmonized tripartite guideline, Validation of analytical procedures, text and methodology Q2 (R1). In: Proceedings of the International Conference on Harmonization of Technical requirements for Registration of Pharmaceuticals for Human Use. London: UK; 1996.
30. Folin O, Ciocalteu V. On Tyrosine and Tryptophane determinations in proteins. J Biochem 1927;73:627â€“50.
31. Basavaiah K, Prameela HC. Spectrophotometric determination of diclofenac sodium using folin ciocalteu reagent in bulk drug and in dosage form. East Pharm 2002;1:61â€“3.
32. Murthy TK, Shankar GD, Rao YS. Visible spectrophotometric methods for the determination of Trimetazidine dihydrochloride in pharmaceutical formulations. Indian Drugs 2002;39:230-3.
33. Basavaiak K, Prameela HC. Simple spectrophotometric determination of acyclovir in bulk drug formulations. II Farmaco 2002;57:443-9.
34. Sastry CSP, Lingeswara Rao JSVM. Spectrophotometric methods for the determination of Methotrexate in pharmaceutical formulations. Anal Lett 1996;29:1763-78.
35. Sastry CSP, Naidu PY, Murthy SSN. Spectrophotometric methods for the determination of Omeprazole in bulk form and pharmaceutical formulations. Talanta 1997;44:1211-7.
36. Sastry CSP, Sailaja A, Rao TT, Krishna DM. Three simple spectrophotometric methods for the determination of Sulphinpyraone. Talanta 1992;39:709-13.
37. Sadler NP, Jacobs H. Application of the Folin Ciocalteu reagent to the determination of Salbutamol in pharmaceutical preparations. Talanta 1995;42:1385-8.
38. Prasad AV, Devi PA, Sastry CS, Prasad UV. Assay of minocycline and tylosin using folin ciocalteu reagent. East Pharm 2003;2:67-8.
39. Murthy TK, Shankar GD, Rao YS. Visible spectrophotometric methods for the determination of Trimetazidine dihydrochloride in pharmaceutical formulation. Indian Drugs 2002;39:230-3.
40. Raghuveer S, Avadhanulu AB, Pantulu AR. Spectrophotometric determination of Gliclazide in its pharmaceutical dosage forms using Folin Ciocalteu reagent. East Pharm 1992;35:129-30.
41. Swamy N, Prashanth KN, Basavaiah K. Redox-reaction based spectrophotometric assay of Isoniazid in pharmaceuticals. Int scholarly research notices. Anal Chem 2014. DOI.org/10.1155/2014/717019 [Article in Press].