Determination of Cyproheptadine Hydrochloride Content in Tablets Using HPLC-PDA Method
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Dhea Aulya Hidayah, Andi Suhendi, Ahmad Fauzi (2026). Determination of Cyproheptadine Hydrochloride Content in Tablets Using HPLC-PDA Method. Journal of Pharmaceutical and Sciences, JPS Volume 9 Nomor 4 (2026). https://doi.org/10.36490/journal-jps.com.v9i4.1850
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Abstract
Cyproheptadine hydrochloride is an antihistamine drug widely used in the treatment of allergic conditions and requires comprehensive quality control evaluation to ensure the accuracy, consistency, and safety of the active pharmaceutical ingredient in tablet preparations. This study aimed to verify the High Performance Liquid Chromatography (HPLC) method and determine the assay and content uniformity of cyproheptadine hydrochloride in several commercial tablet products. The analysis was performed using an HPLC system equipped with a C18 column, a mobile phase consisting of acetonitrile and 0.1% acetic acid (60:40), and a Photodiode Array (PDA) detector at a wavelength of 285 nm. Method verification was carried out based on system suitability, method precision, and accuracy parameters. The results showed that the analytical method met the required criteria, with a correlation coefficient >0.98, method precision (%RSD) of 1.47%, and percentage recovery (%recovery) of 99.51%. The assay determination of five brands of cyproheptadine hydrochloride tablets with a labeled strength of 4 mg showed average drug content values ranging from 98.6–103.3%, with standard deviation values between 1.61–1.95, which complied with the requirements of the Indonesian Pharmacopoeia Sixth Edition (90–110%). Furthermore, the content uniformity test results showed Acceptance Value (AV) values ranging from 4.05–8.06, fulfilling the requirement of L1 < 15.0. Therefore, all tested samples met the established quality standards. In conclusion, the verified HPLC-PDA method can be reliably applied for the quantitative analysis of cyproheptadine hydrochloride in tablet formulations. The findings indicate that all tested commercial tablet products demonstrate consistent pharmaceutical quality and comply with applicable quality standards
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