International Journal of Drug Delivery Technology
Volume 14, Issue 1

Green Analytical HPLC Method Development of Acyclovir Loaded Floating Raft Formulation in Spiked Rabbit Plasma

Rajalakshmi Munusamy, Kola Hepzhibah, Sangeetha Shanmugasundharam*

Department of Pharmaceutics. SRM College of Pharmacy, SRMIST, Kattankulathur, Tamil Nadu, India

Received: 08th January, 2024; Revised: 12th February, 2024; Accepted: 25th February, 2024; Available Online: 25th March, 2024

ABSTRACT

Objective: The need of this investigation is to design eco-friendly, sensitive, and precise bioanalytical high-performance liquid chromatography (HPLC) techniques that leverage green analytical tools such as green analytical procedure index (GAPI), analytical eco scale (AES), and analytical greenness metric (AGREE) to analyze ACV-spiked rabbit plasma and ACV-loaded floating raft formulation (FRF) because The literature survey revealed insufficient data for the HPLC approach to FRF.

Method: Methods involving plasma spikes mirroring the in-vivo models provide insights into potential real-life scenarios and the functionality of floating raft formulations loaded with ACV. The Design Expert tool optimized critical process parameters and identified significant factors influencing the chromatographic technique.

Results: The CCD was used to optimize the flow rate (0.6 mL/min) and buffer solvent ratio (99:1) for separation. The C18 column (250 X 4.6 mm) was utilized to achieve the elution of ACV. The developed method was thoroughly validated through ICH guidelines. The ACV, lower limit of detection (LLoD), and lower limit of quantitation (LLoQ) retention times were established at 2.3 minutes, 15, and 20 ng/mL, respectively.

Discussion: In summary, the study demonstrated the exceptional performance sensitivity, specificity, and robustness of the bioanalytical method. The method proved highly effective in quantifying ACV in plasma samples in terms of revalidatability, transferability, reproducibility, and the product development cycle. The developed method proves that using both design of experiments (DoE) and green analytical chemistry together creates a valid, eco-friendly, and reliable way to analyze the making of an ACV-loaded floating raft formulation.

Keywords: Acyclovir, Green analytical chemistry, HPLC, Spiked rabbit plasma, Floating raft formulation.

International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.48

How to cite this article: Munusamy R, Hepzhibah K, Shanmugasundharam S. Green Analytical HPLC Method Development of Acyclovir Loaded Floating Raft Formulation in Spiked Rabbit Plasma. International Journal of Drug Delivery Technology. 2024;14(1):338-344.

REFERENCES
  1. Hassan H, Omenes O Bello R, Adam siti, Alias, Meor Mohd Redzuan Meor Mohd Affandi E. Acyclovir-Loaded Solid Lipid Nanoparticles: Optimization, Characterization and Evaluation of Its Pharmacokinetic Profile - PMC. Nanomater. 2020;10(9):1785 Available from: doi.org.10.3390/nano10091785
  2. Manoharan G, Mohamed Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Aciclovir in Bulk and Ointment Dosage Form. eIJPPR. 2019;9(1):11-18
  3. Muralidharan S, Kalaimani J, Parasuraman S, Dhanaraj SA. Development and validation of acyclovir HPLC external standard method in human plasma: Application to pharmacokinetic studies. Adv Pharm 2014;2014:1–5. Available from: doi.org. 1155/2014/284652
  4. Narendra N, Jeyabalan Simultaneous estimation of saxagliptin hydrochloride and metformin hydrochloride in active pharmaceutical ingrident by RP-HPLC. Asian JPHCS. 2012;4(3):70–7.
  5. Alqahtani SM, Altharawi A, Altamimi MA, Alossaimi MA, Mahdi WA, Ramzan M, et Method development, stability, and pharmacokinetic studies of acyclovir-loaded topical formulation in spiked rat plasma. Processes (Basel) 2022;10(10):2079. Available from: doi.org. 10.3390/pr10102079
  6. Hailat M, Al-Ani I, Hamad M, Zakareia Z, Abu Dayyih W. Development and validation of a method for quantification of Favipiravir as COVID-19 management in spiked human Molecules 2021;26(13):3789. Available from: doi.org.10.3390/ molecules26133789
  7. Zendelovska D, Simeska S, Atanasovska E, Georgievska K, Kikerkov I, Labachevski N, et Determination of Acyclovir in Human Plasma Samples by HPLC Method with UV Detection: Application to Single-Dose Pharmacokinetic Study. Maced J Med Sci 2015;3(1):32–6. Available from: doi.org. 10.3889/ oamjms.2015.011
  8. Gusai T, Dhavalkumar M, Soniwala M, Dudhat K, Vasoya J, Chavda Formulation and optimization of microsponge-loaded emulgel to improve the transdermal application of acyclovir—a DOE based approach. Drug Deliv. Transl. 2021;11(5):2009–29. Available from: doi.org.10.1007/s13346-020-00862-w
  9. Perumal DD, Krishnan M, Lakshmi Eco-friendly based stability-indicating RP-HPLC technique for the determination of escitalopram and etizolam by employing QbD approach. GCLR. 2022;15(3):671–82. Available from: doi.org. 10.1080/17518253.2022.2127334
  10. Saraya RE, Hassan YF, Eltoukhi WE, Salman Application of the green analytical procedure index to the simultaneous analysis of co-formulated tinidazole and ciprofloxacin in pure form, tablet dosage form, and human plasma using an environmentally friendly micellar high-performance thin-layer chromatographic technology. JPC-J Planar Chromat 2023;36(1):21–30. Available from: doi.org.10.1007/s00764-023-00225-4
  11. Alqirsh SM, Magdy N, Abdel-Ghany MF, El Azab A comparative study of green solid contact ion selective electrodes for the potentiometric determination of Letrozole in dosage form and human plasma. Sci Rep 2023;13(1):20187. Available from: doi.org. 10.1038/s41598-023-47240-3
  12. Dharuman N, Lakshmi KS, Krishnan Environmental benign RP-HPLC method for the simultaneous estimation of anti-hypertensive drugs using analytical quality by design.GCLR. 2023;16(1):2214176. Available from: doi.org. 10.1080/17518253.2023.2214176.
  13. Imam MS, Abdelazim AH, Batubara AS, Gamal M, Almrasy AA, Ramzy S, et al. Simultaneous green TLC determination of nirmatrelvir and ritonavir in the pharmaceutical dosage form and spiked human plasma. Sci Rep 2023;13(1):6165. Available from: org. 10.1038/s41598-023-32904-x
  14. Ajima U, Onah Spectrophotometric determination of acyclovir after its reaction with ninhydrin and ascorbic acid. Appl. Pharm. Sci. 2015;5(4):65–69. Available from: doi.org. 10.7324/JAPS.2015.50411
  15. Bahri-Najafi R, Mostafavi A, Tavakoli N, Taymouri S, Shahraki M-M. Preparation and in vitro-in vivo evaluation of acyclovir floating tablets. Res Pharm Sci 2017;12(2):128–36. Available from: doi.org. 10.4103/1735-5362.202451.
  16. Lisa M; R, Guy, RH. Novel Imaging Method to Quantify Stratum Corneum in Dermatopharmacokinetic Studies: Proof- of-Concept with Acyclovir Formulations. Pharmaceutical Research; 2012;29(12):3362–72. Available from: doi.org.10.1007/ s11095-012-0831-4
  17. Shin S, Kim TH, Jeong SW, Chung SE, Lee DY, Kim DH, et Development of a gastroretentive delivery system for acyclovir by 3D printing technology and its in vivo pharmacokinetic evaluation in Beagle dogs. PLoS ONE 2019;14(5):1–17. Available from: doi.org. 10.1371/journal.pone.0216875
  18. Munusamy R, Shanmugasundharam S. Enhanced gastric residence time of acyclovir by floating raft formulation using box-behnken design. Heliyon 2024;10(2):e24301. Available from: org. 10.1016/j.heliyon.2024.e24301
  19. Sankar R, Niharika A, Sireesha S, Koushik O, Himaja V. Development and validation of RP-HPLC method for quantitative estimation of acyclovir in bulk drug and tablets. JCHPS. 2015;8(1):73–80.
  20. Sai Vijay M, Viswanath Guptha D, Muddu Krishna BS, Vasantharaju SG. Stability indicating assay method development and validation of naratriptan hydrochloride by RP–HPLC. 2016;9(8):1177–82. Available from: doi.org. 10.5958/0974- 360X.2016.00225.0
  21. Haniza Hassan, Siti Khadijah Adam, Ekram Alias second, Meor Mohd Redzuan Meor Mohd Affandi third, Ahmad Fuad Shamsuddin fourth, Rusliza Basir. Central Composite Design for Formulation and Optimization of Solid Lipid Nanoparticles to Enhance Oral Bioavailability of Acyclovir. Molecules 2021;26(18):5432. Available from: doi.org.10.3390/
  22. Stulzer HK, Tagliari MP, Murakami FS, Silva MAS, Laranjeira MCM. Development and Validation of an RP-HPLC Method to Quantitate Acyclovir in Cross-Linked Chitosan Microspheres Produced by Spray J. Chromatogr. Sci. 2008;46(6):496–Available from: doi.org.10.1093/chromsci/46.6.496
  23. Vasudev SS, Ahmad FJ, Khar RK, Bhatnagar A, Kamal YT, Talegaonkar S, et al. Validated HPLC method for the simultaneous determination of taxol and ellagic acid in a Punica granatum fruit extract containing combination formulation. Pharmazie 2012;67(10):834–8.
  24. Hasan S, Chander P, Ali J, Baboota S, Ali M. A new validated ultra performance liquid chromatographic method for determination of Drug Test Anal. 2011;3(3):187–190. Available from: doi.org. 10.1002/dta.201
  25. Ate M, Sinan Kaynak M, Şahin S. Simultaneous Determination of Acyclovir, Metoprolol and Phenol Red by a RP-HPLC Method for Intestinal Perfusion Studies. Hacet. Univ. J. Fac. Pharm 2011;35(1):146–61.
  26. Silva GR, Caldeira ASP, Damico FM, Takahashi BS, Silva- Cunha A, Fialho Analysis of acyclovir in vitreous humor by a validated HPLC method. Pharmazie 2013;68(4):235–9.
  27. Oruganti K. Development and Validation of RP-HPLC Method for Quantitative Estimation of Acyclovir in Bulk Drug And Tablets. JCHPS 2015;8(1):73–89.
  28. Meka VS, Nali SR, Songa AS, Battu JR, Kolapalli VRM. Statistical optimization of a novel excipient (CMEC) based gastro retentive floating tablets of propranolol HCl and it’s in vivo buoyancy characterization in healthy human volunteers. DARU J Pharm Sci 2012;20(1):21. Available from: doi.org. 1186/2008-2231-20-21