Validation of HPLC for identification of captopril, enalapril, and lisinopril in traditional Indonesian herbal medicine

Authors

  • Liliek Nurhidayati Departemen of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Pancasila, Jakarta, 12640, Indonesia
  • Mawarni Tobing Indonesian Food and Drug Authority Regional Office in Jakarta, Jakarta, 13870, Indonesia
  • Elvi Rahmayuni Indonesian Food and Drug Authority Regional Office in Jakarta, Jakarta, 13870, Indonesia

DOI:

https://doi.org/10.35814/jifi.v24i1.2041

Keywords:

HPL, hypertension, identification, Jamu, medicinal chemistry

Abstract

Traditional Indonesian herbal medicine (Jamu) is widely used for health maintenance and disease  prevention. The addition of medicinal chemicals to Jamu is not in accordance with quality and safety requirements. The purpose of this study was to develop a valid HPLC method for the identification of captopril, lisinopril, and enalapril in Jamu for hypertension. In this study, they were identified using high-performance liquid chromatography with a photodiode array detector. The stationary phase was a C18 YMC column (length 250 mm, diameter 4.6 mm, particle size 5 μm), methanol - 0.1 % phosphoric acid (45:55) as the mobile phase with isocratic elution, a flow rate of 1.0 mL/min, a column temperature of 40 °C, an injection volume of 20 μL, and detection at  210 nm. The results showed that this method fulfilled the specificity requirement, with detection limits of captopril, enalapril, and lisinopril of 0.715, 0.795, and 1.403 ppm, respectively. This HPLC method can be used for the identification of captopril, enalapril, and lisinopril in commercial Jamu.

References

[1] WHO, “World Health Statistic,” 2023.

[2] Kemenkes, “Survei kesehatan Indonesia,” 2023, pp. 1–19.

[3] L. L. Herman, S. A. Padala, I. Ahmed, and K. Bashir, “Angiotensin-Converting Enzyme Inhibitors (ACEI) [Updated 2023 Jul 31],” in StatPearls [Internet], Treasure Island (FL): StatPearls Publishing. https://doi.org/10.20527/jps.v11i2.17182

[4] J. L. L. Alvarez, Antihypertensive drugs, I. Croatia: InTech, 2012.

[5] A. Bhagat, H. P. Sonwani, R. Bandey, and M. Mishra, “Studies on various classification of antihypertensive drugs,” Int. Jounal Pharmaceutical Sci., vol. 2, no. 3, pp. 137–146, 2024, https://doi.org/10.5281/zenodo.10781488.

[6] S. N. Y. R. S. Asseggaf and R. Ulfah, “Analisa kepatuhan minum obat antihipertensi pada pasien peserta posyandu lansia kartini surya khatulistiwa Pontianak,” J. Pharmascience, vol. 9, no. 1, p. 48, 2022, https://doi.org/10.20527/jps.v9i1.11870

[7] H. Herman, A. M. Kamri, and A. M. Dahlan, “Comparative effectiveness of antihypertensive drugs,” J. Pharmascience, vol. 11, no. 2, p. 215, 2024, https://doi.org/10.20527/jps.v11i2.17182.

[8] Badan POM RI, “Peraturan Badan Pengawas Obat Dan Makanan nomor 10 Tahun 2024 tentang penandaan obat bahan alam, obat kuasi, dan suplemen kesehatan,” Badan Pengawas Obat dan Makanan, 2024.

[9] Anonim, “Lisinopril: Uses, Interactions, Mechanism of Action,” DrugBank, no. Februari, 2025, [Online]. Available: https://go.drugbank.com/drugs/DB00722[Accessed Nov. 25, 2025].

[10] Anonim, “Captopril: Uses, Interactions, Mechanism of Action,” DrugBank, no. Februari, 2025, [Online]. Available: https://go.drugbank.com/drugs/DB01197[Accessed Nov. 25, 2025]..

[11] Anonim, “Enalapril: Uses, Interactions, Mechanism of Action,” DrugBank, no. Februari, 2025, [Online]. Available: https://go.drugbank.com/drugs/DB00584 [Accessed Nov. 25, 2025]..

[12] Anne Kennedy, Herbal Medicine Natural Remedies. Berkeley: Althea Press, 2017.

[13] Menteri Kesehatan RI, Peraturan Menteri Kesehatan Republik Indonesia Nomor 007 Tahun 2012 tentang Registrasi Obat Tradisional. Jakarta, 2012.

[14] B. P. RI, Pedoman sampling dan pengujian obat tradisional, obat kuasi, suplemen kesehatan, dan kosmetik. Jakarta, 2023.

[15] F. A. Siddiqui, N. Sher, N. Shafi, and S. S. Bahadur, “Concurrent determination of metformin and some ACE inhibitors: Its application to pharmacokinetics,” Arab. J. Chem., vol. 10, pp. S2979–S2987, 2017, https://doi.org/10.1016/j.arabjc.2013.11.035.

[16] Anonim, “Captopril,” The United States Pharmacopeia. National formulary (USP47-NF42). Rockville: MD, 2024.

[17] N. Sultan, S. Naveed, and M. S. Arayne, “RP-HPLC Method for the Simultaneous Determination of Captopril and H2-Receptor Antagonist: Application to Interaction Studies,” Med. Chem. (Los. Angeles)., vol. 03, no. 01, pp. 183–187, 2013, https://doi.org/10.4172/2161-0444.1000136.

[18] L. Logoyda, “Analysis of approaches to the development and validation of the methods of analysis of some active pharmaceutical ingredients from the group of angiotensin converting enzyme inhibitors in drugs and biological liquids,”. J. Appl. Pharm., vol. 11, no. 4, pp. 1–7, 2019, https://doi.org/10.22159/ijap.2019v11i4.32420.

[19] B. G. Chaudhari, “Development and validation of RP-HPLC Method for simultaneous estimation of enalapril maleate and amlodipine besylate in combined dosage form,” J. Appl. Pharm. Sci., vol. 2, no. 9, pp. 054–057, 2012, https://doi.org/10.7324/JAPS.2012.2911.

[20] M. E. Dong, HPLC ınstrumentation in pharmaceutical analysis: Status, advance, and trends: handbook of pharmaceutical analysis by HPLC, I., vol. 6, no. 1. New York: Elsevier Academic Press, 2005.

[21] U. Pharmacopoea, “Validation of Compendial Procedures <1225>,” in United States Pharmacopeia : USP 43 ; The National Formulary : NF 38, Maryland: The United States Book Press, 2020, pp. 8046–8051.

[22] ICH, “ICH Q2 (R2) Guideline on validation of analytical procedures,” in European Medicine Agency, EMA/CHMP/I., vol. 2, no. December 2023, Amsterdam: Science Medicine Health, 2023, pp. 1–33.

[23] Kementerian Kesehatan RI, Farmakope Indonesia edisi VI, VI. Jakarta: DirJend Kefarmasian dan Alkes, Kementerian Kesehatan RI, 2020.

[24] R. B. Pebriana, O. Damayanti, Y. D. Agustin, E. Lukitaningsih, and A. N. Bestari, “Validation of a high-performance liquid chromatographic method for the assay and dissolution of captopril in mucoadhesive tablet formulation,” J. Appl. Pharm. Sci., vol. 11, no. 2, pp. 066–074, 2021, https://doi.org/10.7324/JAPS.2021.110209.

[25] Rohman A. Analisis farmasi dengan kromatografi cair. Yogyakarta: Gadjah Mada University Press; 2019.

[26] Harmita, “Petunjuk pelaksanaan validasi metode dan cara perhitungannya,” Maj. Ilmu Kefarmasian, vol. I, no. 3, pp. 117–135, 2004. https://doi.org/10.7454/psr.v1i3.3375

[27] P. BPOM, “Persyaratan keamanan dan mutu obat tradisional,” Peratur. Badan Pengawas Obat dan Makanan Nomor 32, no. 1294, pp. 1–16, 2019.

Downloads

Published

2026-04-30