QUANTIFICATION AND QUALITY CONTROL OF TRIPLE-DRUG COMBINATION EMPLOYED FOR GASTRIC ULCER USING STABILITY-INDICATING SELECTIVE RP-HPLC TECHNIQUE

YADLA PAVANI; S. ARAVIND; CHARITHA ANNAM; MANNAM SUBBA RAO

doi:10.22159/ijap.2024v16i3.50320

Authors

YADLA PAVANI Freshmen Engineering Department, NRI Institute of Technology, Andhra Pradesh-521212, India https://orcid.org/0009-0002-7998-9933
S. ARAVIND Department of Chemistry, University College of Science, Telangana-500004, India https://orcid.org/0009-0009-7854-6875
CHARITHA ANNAM Department of Humanities and Sciences, VNR Vignana Jyothi Institute of Engineering and Technology, Telangana-500090, India https://orcid.org/0009-0008-7652-9855
MANNAM SUBBA RAO Department of Chemistry, Acharya Nagarjuna University, Guntur-522510, India https://orcid.org/0009-0002-7998-9933

DOI:

https://doi.org/10.22159/ijap.2024v16i3.50320

Keywords:

Helicobacter pylori, Triple combination, Quality control, Voquezna, RP-HPLC, Stability-indicating

Abstract

Objective: A seven-day regimen consisting of vonoprazan (VNP), amoxicillin (AXC) and clarithromycin (CRC), administered twice daily, has been permitted and reimbursed by health coverage as initial therapy. No technique has been implemented yet to determine the quantities of VNP, AXC, and CRC combination. This work effectively aimed at estimating these medications (VNP, AXC, and CRC) at the same time by developing an HPLC technique that saves money and time.

Methods: The VNP, AXC, and CRC were separated in a “Waters” column (C18 nature; 250 mm sized length; 4.6 mm sized internal diameter; 5 µm sized particle; 25 °C temperature). Phosphoric acid (0.1% in water; pH 4.2) and absolute methanol (50:50, v/v) comprise the mobile phase. The drug product, Voqueznatripak, was subjected to hydrolysis, oxidation, photolysis, and thermal stressors with the intent to cause enforced degradation. The suggested "HPLC conditions" were verified in compliance with ICH guidance.

Results: The measurements had a linear range of 10–20 µg/ml for VNP and 250–750 µg/ml for AXC and CRC. The AXC, CRC, and VNP had LOQ’s 5.302 µg/ml, 5.487 µg/ml and 0.523 µg/ml, respectively. Precision measurements were<0.2% RSD and accuracy ranges were 99.40% to 101.46%. The newly devised “HPLC conditions” specificity attribute and stability-indicating quality were also validated by forced degradation tests.

Conclusion: The newly devised “HPLC conditions” for analysing AXC, CRC, and VNP in formulation dosage form and stability samples might be adapted by quality control laboratories. The devised “HPLC conditions” is qualified and consistent to reveal and detect any probable change in the drug product assessments throughout stability experiments.

Downloads

Download data is not yet available.

References

Mohammad KI, Sadaf S, Aiswarya C, Ashif I, Jasjeet KN, Javed A. Combination therapy: past, present, and future. Nanocarriers for the delivery of combination drugs. Micro Nano Techn. 2021;1:1-46. doi: 10.1016/B978-0-12-820779-6.00010-4.

Wang Y, Minden A. Current molecular combination therapies used for the treatment of breast cancer. Int J Mol Sci. 2022;23(19):11046. doi: 10.3390/ijms231911046, PMID 36232349.

Karki N, Kandel K, Shah K, Prasad P, Khanal J. Combination therapy in diabetes mellitus patients attending outpatient department in a tertiary care centre: a descriptive cross-sectional study. JNMA J Nepal Med Assoc. 2022;60(256):1016-20. doi: 10.31729/jnma.7642, PMID 36705114.

Silva JPN, Pinto B, Monteiro L, Silva PMA, Bousbaa H. Combination therapy as a promising way to fight oral cancer. Pharmaceutics. 2023;15(6):1653. doi: 10.3390/pharmaceutics15061653, PMID 37376101.

He B, Lu C, Zheng G, He X, Wang M, Chen G. Combination therapeutics in complex diseases. J Cell Mol Med. 2016;20(12):2231-40. doi: 10.1111/jcmm.12930, PMID 27605177.

de Brito BB, da Silva FAF, Soares AS, Pereira VA, Santos MLC, Sampaio MM. Pathogenesis and clinical management of Helicobacter pylori gastric infection. World J Gastroenterol. 2019;25(37):5578-89. doi: 10.3748/wjg.v25.i37.5578, PMID 31602159.

Oztekin M, Yılmaz B, Agagunduz D, Capasso R. Overview of helicobacter pylori infection: clinical features, treatment, and nutritional aspects. Diseases. 2021;9(4):66. doi: 10.3390/diseases9040066, PMID 34698140.

Akazawa Y, Fukuda D, Fukuda Y. Vonoprazan-based therapy for Helicobacter pylori eradication: experience and clinical evidence. Therap Adv Gastroenterol. 2016;9(6):845-52. doi: 10.1177/1756283X16668093, PMID 27803739.

Liu L, Nahata MC. Vonoprazan with amoxicillin or amoxicillin and clarithromycin for the treatment of helicobacter pylori infection. Ann Pharmacother. 2023;57(10):1185-97. doi: 10.1177/10600280221149708, PMID 36688309.

Kumar V, Bansal V, Madhavan A, Kumar M, Sindhu R, Awasthi MK. Active pharmaceutical ingredient (API) chemicals: a critical review of current biotechnological approaches. Bioengineered. 2022;13(2):4309-27. doi: 10.1080/21655979.2022.2031412, PMID 35135435.

Ozawa S, Chen HH, Lee YA, Higgins CR, Yemeke TT. Characterizing medicine quality by active pharmaceutical ingredient levels: a systematic review and meta-analysis across low- and middle-income countries. Am J Trop Med Hyg. 2022;106(6):1778-90. doi: 10.4269/ajtmh.21-1123, PMID 35895431.

Marra MC, Cunha RR, Munoz RAA, Batista AD, Richter EM. Single-run capillary electrophoresis method for the fast simultaneous determination of amoxicillin, clavulanate, and potassium. J Sep Sci. 2017;40(17):3557-62. doi: 10.1002/jssc.201700478, PMID 28681987.

Magreault S, Leroux S, Touati J, Storme T, Jacqz-Aigrain E. UPLC/MS/MS assay for the simultaneous determination of seven antibiotics in human serum-Application to pediatric studies. J Pharm Biomed Anal. 2019;174:256-62. doi: 10.1016/j.jpba.2019.03.004, PMID 31181488.

Rigo Bonnin R, Ribera A, Arbiol Roca A, Cobo Sacristan S, Padulles A, Murillo O. Development and validation of a measurement procedure based on ultra-high performance liquid chromatography-tandem mass spectrometry for simultaneous measurement of β-lactam antibiotic concentration in human plasma. Clin Chim Acta. 2017;468:215-24. doi: 10.1016/j.cca.2017.03.009, PMID 28288784.

Kathriarachchi UL, Vidhate SS, Al-Tannak N, Thomson AH, da Silva Neto MJJ, Watson DG. Development of a LC-MS method for simultaneous determination of amoxicillin and metronidazole in human serum using hydrophilic interaction chromatography (HILIC). J Chromatogr B Analyt Technol Biomed Life Sci. 2018;1089:78-83. doi: 10.1016/j.jchromb.2018.05.012, PMID 29775840.

do Giang T, Hoang VD. Comparative study of RP-HPLC and UV spectrophotometric techniques for the simultaneous determination of amoxicillin and cloxacillin in capsules. J Young Pharm. 2010;2(2):190-5. doi: 10.4103/0975-1483.63168, PMID 21264124.

Tavakoli N, Varshosaz J, Dorkoosh F, Zargarzadeh MR. Development and validation of a simple HPLC method for simultaneous in vitro determination of amoxicillin and metronidazole at a single wavelength. J Pharm Biomed Anal. 2007;43(1):325-9. doi: 10.1016/j.jpba.2006.06.002, PMID 16859857.

Batrawi N, Wahdan S, Al-Rimawi F. A validated stability-indicating HPLC method for simultaneous determination of amoxicillin and enrofloxacin combination in an injectable suspension. Sci Pharm. 2017;85(1):6. doi: 10.3390/scipharm85010006, PMID 28212319.

Hassib ST, Taha EA, Sharf MG, Mostafa EA. RP-HPLC-DAD method development and validation for simultaneous determination of lansoprazole, tinidazole, amoxicillin, and naproxen in their raw materials and combined dosage form: DOE approach for optimization of the proposed method. J AOAC Int. 2022;105(3):675-87. doi: 10.1093/jaoacint/qsab159, PMID 34918094.

Vu DH, Koster RA, Bolhuis MS, Greijdanus B, Altena RV, Nguyen DH. Simultaneous determination of rifampicin, clarithromycin and their metabolites in dried blood spots using LC-MS/MS. Talanta. 2014;121:9-17. doi: 10.1016/j.talanta.2013.12.043, PMID 24607103.

Ahmed S, Atia NN. Simultaneous determination of triple therapy for Helicobacter pylori in human plasma by reversed phase chromatography with online wavelength switching. Spectrochim Acta A Mol Biomol Spectrosc. 2015;136(C):1380-7. doi: 10.1016/j.saa.2014.10.024, PMID 25459696.

Aktas AH, Saridag AM. Liquid chromatographic-chemometric techniques for the simultaneous HPLC determination of lansoprazole, amoxicillin and clarithromycin in commercial preparation. J Chromatogr Sci. 2017;55(8):798-804. doi: 10.1093/chromsci/bmx039, PMID 28449104.

Sobhy M El-Adl, Mohamed El, Hossinny El Sadek, Marwa Hamdy Hassan. HPLC determination of two cephalosporines with one macrolide in bulk and dosage forms. Asian J Pharm Res. 2014;4(4):180-5.

International conference on the harmonization. ICH Stability testing of new drug substances and products. Vol. Q1A(R2); 2003.

International conference on the harmonization. ICH harmonized tripartite guideline. Validation of analytical procedures: Text and methodology Q2(R1); 2005.

Borman P, Elder D. Q2 (R1) Validation of analytical procedures. ICH Quality Guidelines: an Implementation Guide. 2017;5:127-66.

Naresh P, Kumar KV. Leflunomide tablet formulation: development and validation of an RP-HPLC technique. Int J Pharm Pharm Sci. 2023;15(1):16-21. doi: 10.22159/ijpps.2023v15i1.46505.

Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. Int J App Pharm. 2018;10(6):8-15. doi: 10.22159/ijap.2018v10i6.28279.

Epshtein NA. System suitability requirements for liquid chromatography methods: controlled parameters and their recommended values. Pharm Chem J. 2020;54(5):518-25. doi: 10.1007/s11094-020-02231-w.

Locatelli M, Melucci D, Carlucci G, Locatelli C. Recent HPLC strategies to improve sensitivity and selectivity for the analysis of complex matrices. Instrum Sci Technol. 2012;40(2-3):112-37. doi: 10.1080/10739149.2011.651668.

Betz JM, Brown PN, Roman MC. Accuracy, precision, and reliability of chemical measurements in natural products research. Fitoterapia. 2011;82(1):44-52. doi: 10.1016/j.fitote.2010.09.011, PMID 20884340.

Ferreira SLC, Caires AO, Borges TdS, Lima AMDS, Silva LOB, dos Santos WNL. Robustness evaluation in analytical methods optimized using experimental designs. Microchem J. 2017;131:163-9. doi: 10.1016/j.microc.2016.12.004.

Vyas AJ, Jadav CD, Patel AI, Patel AB, Shah SR, Sheth D. Review on stability-indicating assay method or forced degradation study: strategy and regulatory consideration. Asian J Pharm Anal. 2023;13(2):131-9. doi: 10.52711/2231-5675.2023.00022.

Lakshmi AJ, Abhishek K, Priyanka YL, Balaji PV, Ashritha N. Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of aclidinium bromide and formoterol fumarate in bulk and inhaler formulation. Int J Curr Pharm Sci. 2022;14(5):13-9. doi: 10.22159/ijcpr.2022v14i5.1973.

Nandre DS, Ahmed A, Gj K. Stability indicating HPLC method development and validation for simultaneous estimation of dapagliflozin and metformin tablet dosage form. Asian J Pharm Clin Res 2022;15(10):109-14. doi: 10.22159/ajpcr.2022.v15i10.45616.

Damle MC, Pardeshi RR, Bidkar SR. Development and validation of stability indicating HPTLC method for pimavanserin tartrate. Int J Pharm Pharm Sci. 2023;15(10):17-23. doi: 10.22159/ijpps.2023v15i10.48820.