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All Journal JURNAL FARMASIMED (JFM) Indonesia Natural Research Pharmaceutical Journal (INRPJ)
Arbah, Windy Annisa
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Biochemistry, Genetics & Molecular Biology Chemistry Immunology & microbiology Medicine & Pharmacology

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Validasi Metode dan Penetapan Kadar Olopatadine HCl Pada Obat Tetes Mata Menggunakan Spektrofotometer UV Handoyo, Theodorus Rexa; Djohansah, Violetta; Arbah, Windy Annisa
INDONESIA NATURAL RESEARCH PHARMACEUTICAL JOURNAL Vol 10, No 1 (2025)
Publisher : Fakultas Farmasi Universitas 17 Agustus 1945 Jakarta

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.52447/inrpj.v10i1.8642

Abstract

Olopatadin HCl merupakan antihistamin generasi kedua dengan mekanisme kerja ganda, yaitu antagonis selektif reseptor histamin H₁ dan stabilisasi membran sel mast, yang efektif untuk terapi alergi seperti konjungtivitis dan rinitis alergi. Penelitian ini bertujuan memvalidasi metode spektrofotometri UV–Vis untuk penetapan kadar olopatadin HCl dalam sediaan obat tetes mata yang beredar di Indonesia. Metode dikembangkan dengan larutan standar pada rentang konsentrasi 20–80 ppm, penentuan panjang gelombang maksimum, serta pengujian parameter validasi meliputi linearitas, akurasi, presisi, dan sensitivitas. Hasil menunjukkan panjang gelombang optimum pada 299 nm dengan persamaan regresi y = 25262x + 91851 (r = 0,99). Nilai perolehan kembali sebesar 105,63% dan koefisien variasi 0,52% memenuhi kriteria AOAC, sedangkan batas deteksi (LOD) dan batas kuantifikasi (LOQ) masing-masing sebesar 0,05 ppm dan 0,16 ppm. Kadar olopatadin HCl dalam sampel diperoleh sebesar 0,095 ± 0,001%. Metode ini terbukti sederhana, ekonomis, dan andal, sehingga layak diterapkan untuk pengendalian mutu rutin di laboratorium penelitian maupun industri farmasi.
Development and Method Validation of HPLC Method as an Key Method in the Analysis of Olopatadine HCl Handoyo, Theodorus Rexa; Djohansah, Violetta; Arbah, Windy Annisa
Jurnal FARMASIMED (JFM) Vol 8 No 1 (2025): Jurnal Farmasimed (JFM)
Publisher : Fakultas Farmasi Institut Kesehatan Medistra Lubuk Pakam

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.35451/68pp3f94

Abstract

Olopatadine hydrochloride (HCl) is a widely used second-generation antihistamine, and its accurate quantification is critical to ensure product quality and therapeutic efficacy. Reliable analytical methods are therefore essential for regulatory compliance and routine quality control. This study aimed to develop and validate a simple and robust high-performance liquid chromatography (HPLC) method for the determination of olopatadine HCl in pharmaceutical samples. The method was validated in accordance with USP <1225>, AOAC, and ICH Q2(R1) guidelines, with evaluation of key parameters including linearity, accuracy, precision, selectivity, sensitivity, and system suitability. The validation outcomes confirmed that the method provided strong linearity across the tested range, acceptable recovery values, excellent repeatability, and sufficient sensitivity for low-level detection. Overall, the developed HPLC method proved to be accurate, precise, selective, and reliable. Its simplicity and cost-effectiveness make it particularly suitable for routine quality control of olopatadine HCl in research and pharmaceutical industry laboratories.
Co-Authors Djohansah, Violetta Theodorus Rexa Handoyo