HPLC QUANTITATIVE ANALYSIS OF SIPROFLOKS-АК 250 TABLETS (CIPROFLOXACIN): METHOD DEVELOPMENT, VALIDATION AND ASSAY
DOI:
https://doi.org/10.55640/Keywords:
Ciprofloxacin; Siprofloks-АК; RP-HPLC; method validation; ICH Q2(R1); tablet assay; isocraticAbstract
A reversed-phase HPLC (RP-HPLC) method was developed and validated for the quantitative determination of ciprofloxacin in Siprofloks-АК tablets. Separation was achieved on a C18 column using an isocratic mobile phase composed of phosphate buffer (pH 3.0, 0.025 M) and acetonitrile; detection was performed at 278 nm. The method was validated according to ICH Q2(R1) for specificity, linearity, accuracy, precision, limit of detection (LOD) and limit of quantitation (LOQ). Linearity was observed over 5–50 µg·mL⁻¹ (r² ≥ 0.999), recovery ranged 98.5–101.3% and intra-/inter-day precision RSD was ≤1.8%. The method is simple, precise and suitable for routine quality control of ciprofloxacin tablets such as Siprofloks-АК. (ICH Database)
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1.ICH Q2(R1) — Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation. (Accessed via ICH database). (ICH Database)
2.Scherer R, et al. Determination of Ciprofloxacin in Pharmaceutical Formulations by RP-HPLC. J Chromatogr A / related publication (example method using XBridge C18, detection at 278 nm). PMC article. (PMC)
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7.Yuqori samarali suyuqlik xromatografiyasi (HPLC) yordamida dekserich suyuq ekstraktidagi rutin kontsentratsiyasini tahlil qilish
8.M Axmatoxunova, A Shokirov - Journal of Integrated Education and Research, 2024
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