Development and Validation of Rp-HPLC Method for Simultaneous Estimation of Ciprofloxacin and Fluocinolone Acetonide in Bulk and Pharmaceutical Dosage Form

Abstract

Objective: To develop and validate a reverse phase high performance liquid chromatographic method for simultaneous estimation of ciprofloxacin and fluocinolone acetonide in bulk and pharmaceutical dosage form. Methods: The chromatographic separation was achieved on reverse phase Discovery Inertsil ODS3V Column, C18 (250 mm, 4.6 mm, 5 µm). The separation was achieved by employing the mobile phase consists of phosphate buffer (pH 4) and acetonitrile (40:60). The flow rate was 1.0 ml/min, at a detection wavelength of 295 nm. The proposed method was validated as per the International Council for Harmonisation (ICH) guidelines.Results: The retention time for ciprofloxacin and fluocinolone acetonide was found at 3.627 min and 5.037 min respectively. The proposed method was validated for specificity, accuracy, precision, linearity, the limit of detection (LOD), limit of quantitation (LOQ) and robustness. All validation parameters were within the acceptable range. The assay method was linear and found in the range from 12.5–37.25 µg/ml for ciprofloxacin and 0.625–1.875 µg/ml of fluocinolone acetonide. The relative standard deviation (RSD) values for ciprofloxacin and fluocinolone acetonide were 0.25 % and 0.18 %, respectively. Conclusion: A rapid, accurate and precise RP-HPLC method was developed for the simultaneous estimation of ciprofloxacin and fluocinolone acetonide in bulk and ointment formulation. The developed method was validated for specificity, accuracy, precision, linearity, the limit of detection, limit of quantitation and robustness according to ICH guidelines.

Stability-Indicating Method Development and Validation for the Estimation of Rosuvastatin Calcium in Pharmaceutical Dosage Form by Reverse Phase-High Performance Liquid Chromatography

“…It is an HMG-CoA reductase inhibitor used in the treatment of hypertension, abnormal lipid [1,2]. An extensive literature survey revealed that several HPLC methods were reported for the estimation of rosuvastatin calcium in bulk and tablet formulation [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21]. The International Conference on Harmonization (ICH) guideline entitled "Stability testing of new drug substances and products" requires that stress testing be administered to elucidate the inherent stability characteristics of the active substance [22].…”