Volume : 12, Issue : 10, October – 2025

Title:

RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CIPROFLOXACIN AND LEVOFLOXACIN IN API AND PHARMACEUTICAL FORMULATION

Authors :

P. Pravalika*, Dr. Alivelu Samala, Dr. D. Venkata Ramana

Abstract :

A reliable and efficient Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Ciprofloxacin and Levofloxacin in active pharmaceutical ingredients (APIs) and pharmaceutical formulations. The chromatographic separation was performed on a Symmetry C18 column (4.6 × 150 mm, 5 µm) using a mobile phase of Methanol and Triethylamine (TEA) buffer (pH 4.2) in the ratio 40:60 v/v, at a flow rate of 1.0 ml/min. The detection was carried out at 260 nm using a Waters HPLC system equipped with an auto sampler and PDA Detector (996 model). The column temperature was maintained at 40ºC, and the injection volume was 10 µl, with a run time of 6 minutes. The method was validated in accordance with ICH Q2(R1) guidelines, and parameters such as specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and system suitability were assessed. The results demonstrated that the method is simple, accurate, precise, and robust, with good resolution between both analytes and minimal interference from excipients. This validated method can be effectively applied for the routine quality control and quantitative analysis of Ciprofloxacin and Levofloxacin in both bulk and finished dosage forms.
Keywords: RP-HPLC, Ciprofloxacin, Levofloxacin, Symmetry C18 column, simultaneous estimation, validation

Cite This Article:

Please cite this article in press P. Pravalika et al., Rp-Hplc Analytical Method Development And Validation For Estimation Of Ciprofloxacin And Levofloxacin In Api And Pharmaceutical Formulation, Indo Am. J. P. Sci, 2025; 12(10).

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