Analytical Method Development and Validation for Simulataneous Determination of Amoxicillin, Omeprazole and Rifabutin in Bulk and in a Synthetic Mixture by UV Spectroscopy

  • Vivek Jain Faculty of Pharmacy, Oriental University, Indore, (M.P.) - India
  • Neetesh K. Jain Faculty of Pharmacy, Oriental University, Indore, (M.P.) - India

Abstract

Today Helicobacter pylori (H. pylori) infection is one of the very common bacterial infections worldwide. Upper gastro intestinal tract is primarily affected with this bacterial infection. H. pylori are primarily responsible for dyspepsia, gastric and duodenal ulcers and gastric carcinogenesis and obliteration of the infection has become an important treatment goal in clinical practice. Analysis of multi component formulations by any single analytical method is a very challenging task. A new, simple, precise, accurate, reproducible, and efficient UV spectrophotometric method is developed and validated for the simultaneous estimation of ternary mixture of amoxicillin (AMX), omeprazole (OMP) and rifabutin (RFB) in bulk and in a synthetic mixture which is recently approved by FDA in 2019 to be used for treatment of H. pylori by Vierordt’s method or simultaneous equation method. The solutions of standard and sample were prepared in 0.1 N HCl. The

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Author Biographies

Vivek Jain, Faculty of Pharmacy, Oriental University, Indore, (M.P.) - India

Faculty of Pharmacy, Oriental University, Indore, (M.P.) - India

Neetesh K. Jain, Faculty of Pharmacy, Oriental University, Indore, (M.P.) - India

Faculty of Pharmacy, Oriental University, Indore, (M.P.) - India

References

1. Nishizawa T, Suzuki H, Nakagawa I et al.: Early Helicobacter pylori eradication restores sonic hedgehog expression in the gastric mucosa of Mongolian gerbils. Digestion 2009; 79:99–108.
2. Nishizawa T, Suzuki H, Nakagawa I et al.: Rebamipide-promoted restoration of gastric mucosal sonic hedgehog expression after early Helicobacter pylori eradication. Digestion 2009; 79:259–262.
3. Suzuki H, Iwasaki E, Hibi T: Helicobacter pylori and gastric cancer. Gastric Cancer 2009; 12:79–87.
4. Suzuki H, Suzuki M, Imaeda H et al.: Helicobacter pylori and microcirculation. Microcirculation 1–12 (2009) (Epub ahead of print).
5. Fuccio L, Zagari RM, Eusebi LH et al.: Meta-analysis: can Helicobacter pylori eradication treatment reduce the risk for gastric cancer? Ann. Intern. Med. 2009; 151:121–128.
6. Nishizawa T, Suzuki H, Masaoka T et al.: Helicobacter pylori eradication restored sonic hedgehog expression in the stomach. Hepatogastroenterology 2007; 54:697–700.
7. Fukase K, Kato M, Kikuchi S et al.: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label,randomised controlled trial. Lancet 2008; 372:392–397.
8. Malfertheiner P, Megraud F, O’Morain C et al.: Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 2007; 56:772–781.
9. Suzuki H, Nishizawa T, Hibi T: Therapeutic strategies for functional dyspepsia and the introduction of the Rome III classification. J. Gastroenterol. 2006; 41:513–523.
10. Namrata Singh., Pandurangan, A., Kavita, R., PreetiAnand., Arshad, A. and Amit Kumar, T. Benzimidazole: A short review of their antimicrobial activities. International current pharmaceutical journal, 2012; 5(1):119-127.
11. Indian Pharmacopoeia. Government of India, Ministry of Health and Family Welfare, Ghaziabad, New Delhi, The Indian pharmacopoeia commission publisher, 2010; 1813-1814.
12. United States of Pharmacopoeia. Convention inc., Rockville, 2009; 2796-2797.
13. Stephen, B., Armagan, O. and Aysel, O. Analytical method development and validation for omeprazole capsules and blend using UV spectrophotometry. Indian journal of pharmaceutical sciences, 2006; 64(10):194-213.
14. Jha P, Parveen R, S. Khan A, Alam O, Ahmad S, Stability-indicating high-performance thin-layer chromatographic method for quantitative determination of omeprazole in capsule dosage form. J. AOAC Int., 2010; 93(3):787–791.
15. Z. Ma, L. Zhang, L. Lin, P. Ji and X. Guo, Enantioseparation of rabeprazole and omeprazole by nonaqueous capillary electrophoresis with an ephedrine-based ionic liquid as the chiral selector. Biomed. Chromatogr., 2010; 1332–1337.
16. Harshal, K.T. and Mukesh, C.P. Development and Validation of a precise single HPLC Method for Determination of Omeprazole and its related compound in pharmaceutical formulation. Indian journal of pharmaceutical sciences, 1997; 59(3):124-127.
17. Motevalian, M., Saeedi, G., Keyhanfar, F. and Tayebi, M. M. Simultaneous Determination of Omeprazole and its Metabolites in Human Plasma by HPLC using Solid-phase Extraction. Journal of Pharmaceutical and Biomedical Analysis, 2008; 85(4):265–268.
18. Inger, G., Jerndal, G., Balmér, K. and Persson. Fully automated gradient elution liquid chromatographic assay of omeprazole and two metabolites. Journal of Pharmaceutical and Biomedical Analysis, 1986; 54(4):389- 398.
19. Cristina, I., Mirela, M., Adina, P. and Leucuţa, S. E. Validation of HPLC- UV method for analysis of omeprazole in presence of its metabolites in human plasma, Farmacia, 2008; 3(1):234-242.
20. Dong-SeokYim., JuEunJeong. Ji Young Park. Assay of omeprazole and omeprazole sulfone by semimicrocolumn liquid chromatography with mixed-function precolumn. Journal of Chromatography B: Biomedical Sciences and Applications, Volume 2001; 754(2):487-493
21. Kirti S.T., Rajesh M.J., Purushotam K.S. and Mrinalini C. D. A validated normal phase HPLC method for simultaneous determination of drotaverine hydrochloride and omeprazole in pharmaceutical formulation. Asian Journal of Pharmaceutical and Clinical Research, 2010; 3(1):974- 986.
22. Nataraj KS, Duza MB, Pragallapati K, Kumar DK. Development and validation of RP-HPLC method for the estimation of omeprazole in bulk and capsule dosage forms. International Current Pharmaceutical Journal 2012; 1(11):366-369.
23. Dousa M, Hosmanova R. Rapid determination of amoxicillin in premixes by HPLC. J Pharm Biomed Anal. 2005; 7(2):373–7.
24. Vu DH, Do TG. Comparative study of RP-HPLC and UV spec - trophotometric techniques for the simultaneous determination of amoxicillin and cloxacillin in capsules. J Young Pharmacist. 2010; 2(2):190–5.
25. Nikam DS, Bonde CG, Surana SJ, Venkateshwarlu G, Dekate PG. Development and validation of RP-HPLC method for simultaneous estimation of amoxicillin trihydrate and fucloxa - cillin sodium in capsule dosage form. Int J Pharm Tech Res. 2009; 1(3):935–9.
26. Shanmugasundaram P, Raj RK, Mohanrangan J, Devdass G, Arunadevi M, Maheswari R, Aanandhi MV. Simultaneous esti - mation of amoxicillin and fucloxacillin in its combined capsule dosage form by HPLC. Rasayan J Chem. 2009; 2:57–60.
27. Patel P, Varshney P, Minal R, Analytical method development and validation for simultaneous estimation of amoxicillin trihydrate and metronidazole in synthetic mixture by UV-Visible spectroscopy, Int. J. Pharm. Pharm. Sci., 2014; 6(2):317-319.
28. Dhoka MV, Gawande VT, and Joshi PP, Simultaneous estimation of amoxicillin trihydrate and bromhexine hydrochloride in oral solid dosage forms by spectrophotometric method, Int. Res. J. Pharm., 2011; 2(3):197-201.
29. Mali AD, Hake G Tamboli A, Zero order and area under curve spectrophotometric methods for determination of amoxicillin trihydrate in pharmaceutical formulation, Innovare Journal of Sciences, 2016; 4(1):8-11.
30. Dangi YS, Soni ML Namdeo KP, A UV spectrophotometric method developed for the simultaneous estimation of amoxicillin trihydrate and ranitidine bismuth citrate for helicobacter pylori infections, Der Pharmacia Sinica, 2016; 1(3):11-16
31. Solanki RS, Nagori BP, Naval MK, Banerjee J. Development and validation of simultaneous estimation method for amoxicillin trihydrate and tinidazole in tablet dosage form by RP-HPLC, Asian J. Pharm. Ana., 2013; 3(2):66-71.
32. Patil JK, Patil KA, Pawar SP, Development and validation of RP-HPLC method for simultaneous estimation of amoxicillin and dicloxacillin in bulk drug and capsules, Int. J. Pharm. Sci., 2014; 5(2):39-47.
33. Sabrya SM, Abdel-Haya MH, Belal TS, Mahgoub AA. Development and validation of HPLC-DAD method for the simultaneous determination of amoxicillin, metronidazole and rabeprazole sodium. Application to spiked simulated intestinal fluid samples. Ann Pharm Fr (2015), http://dx.doi.org/10.1016/j.pharma.2015.04.008
34. Mustafa Gülfen, Yazgı Canbaz, Abdil Özdemir. Simultaneous Determination of Amoxicillin, Lansoprazole, and Levofoxacin in Pharmaceuticals by HPLC with UV–Vis Detector Journal of Analysis and Testing 2020; 4:45–53
35. Mohamed M. Baraka, Mohamed E. Elsadek, Arwa M. Ibrahim. HPLC method for the simultaneouus determination of secnidazole, omeprazole and amoxicillin mixture in pure forms and pharmaceutical formulations. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2014; 2(4):197-207.
36. Hakan Aktas A¸ Sarıdag AM. Liquid Chromatographic–Chemometric Techniques for the Simultaneous HPLC Determination of Lansoprazole, Amoxicillin and Clarithromycin in Commercial Preparation. Journal of Chromatographic Science, 2017; 55(8):798–804
37. Dhoka MV, Gawande VT, Joshi PP. HPTLC determination of amoxicillin trihydrate and bromhexine hydrochloride in oral solid dosage forms, J. Pharm. Sci. & Res, 2010; 2(8):477-483.
38. El Walily A F, Gazy A A, Belal S F, Khamis E F. Selective spectrofluorimetric determination of phenolic beta-lactum antibiotics through the formation of their coumarin derivatives, J Pharm Biomed Anal, 1999; 20(4):643-653.
39. D. Ungheri, C. Delia Brunna, A. Sanfilippo, Studies on the mechanism of action of spiropiperidyl- rifamycin on LM427 rifampicin-resistant M. tuberculosis, Drugs Exp. Clin. Res. 1984; 10:681–689.
40. Graya YA, Waldorf B, Rao MG, Stiles BL, Griffiss JM, Salatac RA, Blumer JL. Development and validation of an LC-MS/MS method for the simultaneous determination of bedaquiline and rifabutin in human plasma. Journal of Pharmaceutical and Biomedical Analysis 2019; 176:112775.
41. Singh G, Srivastava AK, High - performance liquid chromatography method validation and development strategy for rifabutin. International Journal of Pharmaceutical Sciences and Research 2018; 9(9):3903-3907.
42. Hemanth Kumar AK, Sudha V, Ramachandran G. Simple and rapid liquid chromatography method for determination of rifabutin in plasma. SAARC J TUBER LUNG DIS HIV/AIDS 2012; IX (2) 26-29.
43. Patil YD, Banerjee SK. RP-HPLC method for the estimation of Rifabutin in bulk dosage form. International Journal of Drug Development & Research 2012; 4(2):294-297.
44. Jaiswal S, Sharma A, Shukla M, Lal J. Simultaneous LC–MS-MS Determination of Lopinavir and Rifabutin in Human Plasma Journal of Chromatographic Science, 2017; 55(6):617–624
45. Ermolenko Y, Anshakova A, Osipova N, Kamentsev M, Maksimenko O, Balabanyan V, Gelperina S. Simultaneous determination of rifabutin and human serum albumin in pharmaceutical formulations by capillary electrophoresis. Journal of Pharmacological and Toxicological Methods 2017; 85:55–60.
46. ICH Q2 (R1) Guideline, Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland, 2005.
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How to Cite
1.
Jain V, Jain NK. Analytical Method Development and Validation for Simulataneous Determination of Amoxicillin, Omeprazole and Rifabutin in Bulk and in a Synthetic Mixture by UV Spectroscopy. JDDT [Internet]. 30Jul.2019 [cited 6Mar.2021];9(4):788-94. Available from: http://www.jddtonline.info/index.php/jddt/article/view/4211