BEYOND-USE DATE DETERMINATION OF CETIRIZINE HYDROCHLORIDE SYRUP PREPARATION
DOI:
https://doi.org/10.22159/ijap.2025v17i1.52242Keywords:
BUD, Cetirizine, HPLC and Wister Albino ratsAbstract
Objective: To determine Beyond Use Date (BUD) of cetirizine hydrochloride syrup preparation by analyzing cetirizine concentrations using High-Performance Liquid Chromatography (HPLC) with an Ultraviolet (UV) detector.
Methods: The analysis was carried out using mobile phase acetonitrile-phosphate buffer pH 3 (50:50 v/v), flow rate 1 ml/min with isocratic elution, and detected using a UV detector at 232 nm. The BUD was determined by measuring the cetirizine level in the syrup sample since the primary packaging was opened (day 0) for 5 weeks of storage.
Results: The analytical method was selective and specific. The linearity results show a correlation coefficient (r) of 0.9998 in the 4-32 g/ml concentration range. The Limit Of Detection (LOD) and Limit Of Quantification (LOQ) values were 0.5 µg/ml and 1.7 µg/ml, respectively. The method satisfies accuracy, precision, robustness, and ruggedness criteria. The data showed a decrease in cetirizine concentration level in preparation within 5 weeks.
Conclusion: This study successfully determined the BUD of cetirizine hydrochloride syrup by analyzing cetirizine concentrations using HPLC with a UV detector. The results revealed a progressive decrease in cetirizine concentration over five weeks of storage, and the BUD was established at 25 days. This finding is significant, providing valuable guidance for pharmacists and healthcare providers in managing the use of the medicine after the primary packaging is opened
Downloads
References
Badan Pengawas Obat dan Makanan. Peraturan Badan Pengawas Obat dan Makanan Nomor 15 tahun 2022: Penerapan Farmakovigilans. Jakarta:BPOM; 2022 July. 167p.
Herawati F. Beyond Use Date. Rasional. 2012 December. p19-24.
Velagaleti R. Stability and Shelf Life of Pharmaceutical Products. In: Shayne CG, editors. Pharmaceutical Sciences Encyclopedia:Drug Discovery, Development, and Manufacturing. New York: John Wiley & Sons; 2010. p. 1–24. doi: 10.1002/9780470571224.pse390.
Badan Pengawas Obat dan Makanan. Peraturan Badan Pengawas Obat dan Makanan Nomor 24 tahun 2017: Kriteria dan Tata Laksana Registrasi Obat. Jakarta:BPOM; 2017 November. 44p.
Ohler J, Miller C, Sheridan D. How do expiration and beyond-use dates compare?. Nursing. 2019;49(3):17. doi: 10.1097/01.NURSE.0000553290.72084.04.
FDA. USP Compounding Standards and Beyond-Use Dates (BUDs). USA: USP; 2019 p.1–3, [Online]. Available: https://www.usp.org/sites/default/files/usp/document/our-work/compounding/usp-bud-factsheet.pdf
Gilman SA, Blatter M, Condemi JJ, Collins M, Olufade AO, Leidy NK, Chapman D, Kramer B. The health-related quality of life effects of once-daily cetirizine HCl syrup in children with seasonal allergic rhinitis. Clin Pediatr (Phila). 2002;41(9):687-696. doi: 10.1177/000992280204100908.
Portnoy JM, Dinakar C. Review of cetirizine hydrochloride for the treatment of allergic disorders. Expert Opin Pharmacother. 2004;5(1):125–135. doi: 10.1517/14656566.5.1.125.
Zhang L, Cheng L, Hong J. The clinical use of cetirizine in the treatment of allergic rhinitis. Pharmacology, 2013;92(1-2):14-25. doi: 10.1159/000351843.
Lisni I, Anggriani A, Puspitasari R. Kajian Peresepan Obat Antihistamin Pada Pasien Rawat Jalan Di Salah Satu Rumah Sakit Di Bandung. Jurnal Riset Kefarmasian Indonesia. 2020;2(2):52-62.
Bano S, Fatima S, Usman S, Jamil S, Jaweed L, Nawab A. Comparison of Stability of Cetirizine. Asian J of Pharm. 2018;12(3):5–9.
Gupta D, Bhatia D, Dave V, Sutariya V, Gupta SV. Salts of therapeutic agents: Chemical, physicochemical, and biological considerations. Molecules. 2018;23(7):1-15. doi: 10.3390/molecules23071719.
Harmita H. Petunjuk Pelaksanaan Validasi Metode Dan Cara Perhitungannya. Maj. Ilmu Kefarmasian. 2004;1(3):117-135. doi: 10.7454/psr.v1i3.3375.
Harron DWG., “Technical Requirements for Registration of Pharmaceuticals for Human Use: The ICH Process,” Textb. Pharm. Med., vol. 1994, no. October 1994, pp. 447–460, 2013, doi: 10.1002/9781118532331.ch23.
Kementrian Kesehatan Republik Indonesia. Farmakope Indonesia edisi VI. Jakarta:Kementrian Kesehatan; 2020 September. 2371p.
Sarker SD, Nahar L. Applications of High Performance Liquid Chromatography. In: Mukherjee PK, editors. Evidence-Based Validation of Herbal Medicine. the Analysis of Herbal Products. New York: Elsevier; 2015. p. 405-425. doi: 10.1016/B978-0-12-800874-4.00019-2.
Eriksson KO. Reversed Phase Chromatography. Amersham Biosciences: Piscataway; 1999. doi: 10.1016/B978-0-08-100623-8.00022-0.
Rajesh R. Stability-Indicating Rp-Hplc Method Development and Validation for the Analysis of Doxepin Hydrochloride in Bulk and Pharmaceutical Dosage Form. Int J Pharm Pharm Sci. 2024;16(4):27-35. doi: 10.22159/ijpps.2024v16i4.50126.
Gilar M, Jaworski A, McDonald TS. Solvent selectivity and strength in reversed-phase liquid chromatography separation of peptides. J Chrom A. 2014;1337:140-146. doi: 10.1016/j.chroma.2014.02.048.
Jaber AMY, Al Sherife HA, Al Omari MM, Badwan AA. Determination of cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC. J Pharm Biomed Anal. 2004;36(2):341-350. doi: 10.1016/j.jpba.2004.07.002.
Souri E, Hatami A, Ravari NS, Alvandifar F, Tehrani MB. Validating a stability indicating HPLC method for kinetic study of cetirizine degradation in acidic and oxidative conditions. Iran J Pharm Res. 2013;12(2):287–294.
Khan MI, Murtaza G, Awan S, Iqbal M, Wagas MK, Rasool A, Fatima U, Hassham M, Kahlid A, Usman F, Najam Q, Khan SA, Farzana K, Mahmood S, Hussain I. Development and validation of stability indicating assay method of cetirizine hydrochloride by HPLC. African J Pharm Pharmacol. 2011;5(2):143–149. doi: 10.5897/AJPP10.283.
Sultana N, Arayne MS, Sharif S. Levofloxacin interactions with essential and trace elements. Pak J Pharm Sci. 2004;17(2): 67–76.
Hasan N, Chaiharn M, Toor UA, Mirani ZA, Sajjad G, Sher N, Aziz M, Siddiqui FA. Development, Validation and Application of RP-HPLC Method: Simultaneous Determination of Antihistamine and Preservatives with Paracetamol in Liquid Formulations and Human Serum. Open Med Chem J. 2016;10(1):33–43. doi: 10.2174/1874104501610010033.
Aswathy SR, Muhas C, Sruthy A, Swapna D, Gopinath U. Validation and Application of RP-HPLC Method for Quantification of Enrofloxacin in Pure and Veterinary Dosage Forms. Int. J. Pharm. Pharm. Sci. 2022;14(2):42-47 doi: 10.22159/ijpps.2022v14i2.43053.
Manoranjani M, Satyadev TNVSS. Raju MD. a Reverse Phase Ultra Performance Liquid Chromatography-Photo Diode Array Estimation of Captopril and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Form. Int. J. Appl. Pharm. 2024;16(4):267–274. doi: 10.22159/ijap.2024v16i4.49857.
Murugesan A, Annapurna MM. Simple Quantified and Validated Stability Indicating Stress Degradation Studies of Oral Anti-Diabetic Agent Dapagliflozin By RP-HPLC Method. Int. J. Appl. Pharm. 2022;14(1):231–237. doi: 10.22159/ijap.2022v14i1.43482.
Jatmika C, Iswandana R, Lestari ID, Beyond Use Date (BUD) Determination of Ambroxol Hydrochloride Syrup by High-Performance Liquid Chromatography–UV- VIS Detector Abstract. Pharm Sci Res. 2023;10(1): 29–37.
Wang LS, Wei XL, Gong Q, Jiang ZL, Li DM, Liang Q. Indirect determination of cetirizine hydrochloride by ICP-AES. Bull Korean Chem. Soc. 2011;32(2):595–598. doi: 10.5012/bkcs.2011.32.2.595.
Published
How to Cite
Issue
Section
Copyright (c) 2024 Catur Jatmika, Raditya Iswandana, Ghina Salma Fadhila
This work is licensed under a Creative Commons Attribution 4.0 International License.
