BEYOND-USE DATE DETERMINATION OF CETIRIZINE HYDROCHLORIDE SYRUP PREPARATION

Authors

  • CATUR JATMIKA Laboratory of Pharmaceutical Chemistry, Medicinal, and Bioanalysis, Faculty of Pharmacy, Universitas Indonesia, Depok, West Java, Indonesia https://orcid.org/0000-0002-9998-7292
  • GHINA SALMA FADHILA Laboratory of Pharmaceutical Chemistry, Medicinal, and Bioanalysis, Faculty of Pharmacy, Universitas Indonesia, Depok, West Java, Indonesia
  • RADITYA ISWANDANA Laboratory of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Indonesia, Depok, West Java, Indonesia https://orcid.org/0000-0003-2637-3844

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52242

Keywords:

BUD, Cetirizine, HPLC and Wister Albino rats

Abstract

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

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Published

26-10-2024

How to Cite

JATMIKA, C., FADHILA, G. S., & ISWANDANA, R. (2024). BEYOND-USE DATE DETERMINATION OF CETIRIZINE HYDROCHLORIDE SYRUP PREPARATION. International Journal of Applied Pharmaceutics, 17(1). https://doi.org/10.22159/ijap.2025v17i1.52242

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