DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM
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.
2. Najmul H, Farhan Ahmed S, Nawab S, Nighat S, Arif Z, Muhammad A. Development and validation of a reverse phase HPLC method for the analysis of ciprofloxacin and its application in bulk and different dosage formulations. World Appl Sci J 2014;31:730-40.
3. Konieczna CL, Lamparczyk H. Development of a reversed-phase HPLC method for analysis of fluocinolone acetonide in gel and ointment. Acta Chromatogr 2006;16:80-91.
4. Tagalpallewar VR, Indurwade NH, Kakarwal DD, Moon AG. Development and validation of analytical methods for simultaneous estimation of ciprofloxacin and tinidazole in bulk and marketed formulation. Int J Pharm Chem Sci 2014;3:168-74.
5. Sanjay SP, Tukaram MK, Seema SK. RP-HPLC method development and validation for simultaneous estimation of bromhexine and ciprofloxacin in tablet dosage form. Der Pharma Chemica 2014;6:90-7.
6. Khadabadi SS, Meenakshi G. A validated RP-HPLC method for simultaneous estimation of metronidazole and ciprofloxacin hydrochloride in pharmaceutical dosage form. Int J Pharm Sci Res 2013;4:4736-40.
7. Syeda K, Rahul Reddy C, Kanaka Durga M, Padmalatha M. A simple and validated RP-HPLC method for the simultaneous estimation of tinidazole and ciprofloxacin in bulk and pharmaceutical dosage forms. Int J Res Dev Pharm Life Sci 2013;2:238-43.
8. Katakam P, Karanam R. Simultaneous determination of ciprofloxacin hydrochloride and dexamethasone sodium phosphate in eye drops by HPLC. E J Chem 2012;9:1077-84.
9. Patel AB, Shah NJ, Patel NM. Simultaneous estimation of satranidazole and ciprofloxacin by RP-HPLC method in tablet dosage form. Int J Chem Sci 2009;7:2108-14.
10. Balaswami B, Venkata Ramana P, Subba Rao B, Sanjeeva P. A new stebility indicating RP-HPLC-PDA method for simultaneous estimation of neomycin and fluocinolone in pharmaceutical tablet dosage form. Int J Pharm Sci Res 2018;9:4187-93.
11. Bhavini Milankumar P. Development and validation of RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and fluocinolone acetonide in their synthetic mixture. Indo Am J Pharm 2017;7:8220-9.
12. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Validation of analytical procedures; Text and methodology ICH Q2 (R1); 2005.
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