PHYSICAL AND CHEMICAL STABILITY TEST OF NEEM OIL CREAM (Azadirachta indica) USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

  • FEBRINA AMELIA SAPUTRI Universitas Indonesia https://orcid.org/0000-0002-9201-8018
  • PATIHUL HUSNI Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Bandung, Indonesia
  • NORISCA ALIZA PUTRIANA Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Bandung, Indonesia

Abstract

Objective: This study aims to examine the physical and chemical stability of neem oil cream.


Methods: Physical stability was conducted by storing the cream at room temperature (25 ± 2 °C / 65 %RH ± 5 %RH) and high temperature (40 ± 2 °C / 75 %RH ± 5 %RH) for 3 months. Method validation using Dionex HPLC with UV detector, Shodex (C-18) HPLC packed column (4.6 mmID x 250 mmL), acetonitrile:water [30:70] as mobile phase, 10 minutes isocratic elution  with a flow rate of 1.0 mL/min with volume injection 20 μL, and UV detection at 219 nm was carried out to measure azadirachtin levels in neem oil cream. Chemical stability of azadirachtin was carried out by the validated method and carried out for 90 days.


Results: The neem oil cream was physically stable. The HPLC method of azadirachtin meets all the validation parameters and can be used to analyze the chemical stability of azadirachtin in neem oil cream. Neem oil cream is stable for 4 weeks at 25 oC and for 1 week at 40 oC.


Conclusion: The neem oil cream is physically stable and chemically stable for 4 weeks at a 25°C and 1 week at 40°C.

Keywords: Azadirachtin, Neem oil cream, Physical stability, Chemical stability, High performance liquid chromatography.

References

1. Alzohairy MA. Therapeutics role of Azadirachta indica (Neem) and their active constituents in diseases prevention and treatment. Evid Based Complement Alternat Med. 2016; 2016, 1-11.
2. Liauw MY, Natan F, Widiyanti P, Ikasari D, Indraswati N, Soetaredjo F. Extraction of neem oil (Azadirachta indica A. Juss) using n-hexane and ethanol: studies of oil quality, kinetic and thermodynamic. ARPN Journal of Engineering Applied Sciences. 2008; 3, 49-54.
3. Ayoola A, Efeovbokhan VE, Bafuwa O, David O. A search for alternative solvent to hexane during neem oil extraction. International Journal of Science Technology. 2014; 4, 66-70.
4. Johnson S, Morgan ED. Supercritical fluid extraction of oil and triterpenoids from neem seeds. Phytochemical Analysis. 1997; 8, 228-232.
5. Abdel-Ghaffar F, Al-Quraishy S, Al-Rasheid KA, Mehlhorn H. Efficacy of a single treatment of head lice with a neem seed extract: an in vivo and in vitro study on nits and motile stages. Parasitol Res. 2012; 110, 277-80.
6. Putriana NA, Hakim A, Husni P, Rusdiana T. In vitro effectiveness of neem oil (Azadirachta Indica A. Juss) shampoo as anti head lice (Pediculus humanus capitis). Pharmacology Clinical Pharmacy Research. 2019; 4, 76-80.
7. Thomas C, Coates SJ, Engelman D, Chosidow O, Chang AY. Ectoparasites: Scabies. J Am Acad Dermatol. 2020; 82, 533-548.
8. Leung AKC, Lam JM, Leong KF. Scabies: a neglected global disease. Curr Pediatr Rev. 2020; 16, 33-42.
9. WHO. Scabies. 2020 [cited 2020 February 25]; Available at: https://www.who.int/news-room/fact-sheets/detail/scabies.
10. Parman P, Hamdani H, Rachman I, Pratama A. Faktor risiko hygiene perorangan santri terhadap kejadian penyakit kulit skabies di pesantren al-baqiyatushshalihat tanjung jabung barat tahun 2017. Jurnal Ilmiah Universitas Batanghari Jambi. 2017; 17, 243-252.
11. Dressler C, Rosumeck S, Sunderkotter C, Werner RN, Nast A. The Treatment of Scabies. Dtsch Arztebl Int. 2016; 113, 757-762.
12. Mayba JN, Gooderham MJ. A guide to topical vehicle formulations. J Cutan Med Surg. 2018; 22, 207-212.
13. Bolla PK, Clark BA, Juluri A, Cheruvu HS, Renukuntla J. Evaluation of Formulation Parameters on Permeation of Ibuprofen from Topical Formulations Using Strat-M((R)) Membrane. Pharmaceutics. 2020; 12.
14. Putriana N, Husni P. Effectiveness test of neem oil cream (Azadirachta indica A. Juss) as antiscabies in New Zealand Rabbits. in International Seminar on Pharmaceutical Science and Technology. 2018. Indonesia: Journal of Pharmaceutical Sciences and Research.
15. Bott RF, Oliveira WP. Storage conditions for stability testing of pharmaceuticals in hot and humid regions. Drug Dev Ind Pharm. 2007; 33, 393-401.
16. Bajaj S, Singla D, Sakhuja N. Stability testing of pharmaceutical products. Journal of applied pharmaceutical science. 2012; 2, 129-138.
17. Husni P, Amalia AD, Mita SR, Putriana NAJI. Formulation and Physical Evaluation of Cream Containing Neem Oil 5%. Indonesian Journal of Pharmaceutics. 2019; 1, 72-76.
18. Lambers H, Piessens S, Bloem A, Pronk H, Finkel P. Natural skin surface pH is on average below 5, which is beneficial for its resident flora. Int J Cosmet Sci. 2006; 28, 359-70.
19. Proksch E. pH in nature, humans and skin. J Dermatol. 2018; 45, 1044-1052.
20. Garg A, Aggarwal D, Garg S, Singla AK. Spreading of semisolid formulations: an update. Pharmaceutical technology. 2002; 26, 84-105.
21. Sopyan I, Gozali D, Tiassetiana S. Formulation of tomato extracts (Solanum lycopersicum L.) as a sunscreen lotion. National Journal of Physiology, Pharmacy Pharmacology. 2018; 8, 453-458.
22. Goodarzi F, Zendehboudi S. A Comprehensive Review on Emulsions and Emulsion Stability in Chemical and Energy Industries. Canadian Journal of Chemical Engineering. 2019; 97, 281-309.
23. International Conference on Harmonization. Q2 Validation of analytical procedures?: text and methodology international conference on harmonization of technical requirements for registration of pharmaceutical for human use, ICH Harmonized Tripartite Guideline. 2005 [cited 2021 March 12]; Available at: https://www.gmp-compliance.org/files/guidemgr/Q2(R1).pdf.
24. PubChem. PubChem Compound Summary for CID 5281303, Azadirachtin. 2021 [cited 2021 February 26]; Available at: https://pubchem.ncbi.nlm.nih.gov/compound/Azadirachtin.
25. Bhuyian MHU, Rasyid DH, Mohsin M, Tahera K. An overview: stability study of pharmaceutical product and shelf life prediction. European of Biomedical Sciences. 2015; 2, 30-40.
Statistics
21 Views | Downloads
Citations
How to Cite
SAPUTRI, F. A., HUSNI, P., & PUTRIANA, N. A. (2021). PHYSICAL AND CHEMICAL STABILITY TEST OF NEEM OIL CREAM (Azadirachta indica) USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD . International Journal of Applied Pharmaceutics, 13(4). https://doi.org/10.22159/ijap.2021v13i4.41539
Section
Original Article(s)