Indexing
All Issues
Submission
Author Guidelines
Reviewers
Editorial Members
Publication Fee
Vol.2 , No. 1, Publication Date: Jan. 28, 2015, Page: 1-8
-1, 4-dihydroquinoline-3-carboxylic acid, is a synthetic broad antibacterial compound belonging to the group of fluoroquinolones. Analytical method development and validation involve a series of activities that are ongoing during the life cycle of a drug product and drug substance. Objectives: The study mainly aims to develop and validate spectrophotometeric assay method for Ciprofloxacin tablet. Instruments chemicals and reagents: Precision balance (Mettler Toledo, AL204-IC, and Switzerland), UV-Vis spectrophotometer (Shimadzu Corporation, UV-2401PC, China), sonicator, mortar and pestle, different glass wares were used throughout the experimental work. Ciprofloxacin 500 mg film coated tablets, Pharmaceutical grade (reference standards) Ciprofloxacin HCl chemical and Distilled water was used as solvent. Methods: The maximum wavelength was taken at which the RS solution showed maximum absorption/peak. The method was validated before according to ICH/USP guidelines for method validation parameters. Quantification was done at selected wavelength using Beer’s Law. Results and Discussion: The maximum wavelength (λ max) of the drug was obtained at 275 nm. The amount of Ciprofloxacin at the selected maximum wave length was found to be 97.93% of the labeled claim. The percent interference for the placebo was found to be 1.59%. The result reveals that there is a strong linear relationship between the concentration of the test sample and the absorbance values over the concentration range 3 to 7 μg/ml of Ciprofloxacin. With a regression equation Y = 0.105X -0.0035 and; r2 = 0.9994. The percent mean recovery obtained was between 98 - 102%.&picture=http://www.aascit.org/aascit/decorators/img/journal/922.jpg)
| [1] | Tadesse Haile Fereja, Department of Pharmacy, College of Medicine and Health Sciences, Ambo University, Oromia region, Ethiopia. |
| [2] | Muluneh Fromsa Seifu, Department of Pharmacy, College of Medicine and Health Sciences, Ambo University, Oromia region, Ethiopia. |
| [3] | Tizita Yirga Mola, Department of Pharmacy, College of Medicine and Health Sciences, Ambo University, Oromia region, Ethiopia. |
Introduction: Spectrophotometeric analysis continues to be one of the most widely used analytical techniques available. Ciprofloxacin, 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1, 4-dihydroquinoline-3-carboxylic acid, is a synthetic broad antibacterial compound belonging to the group of fluoroquinolones. Analytical method development and validation involve a series of activities that are ongoing during the life cycle of a drug product and drug substance. Objectives: The study mainly aims to develop and validate spectrophotometeric assay method for Ciprofloxacin tablet. Instruments chemicals and reagents: Precision balance (Mettler Toledo, AL204-IC, and Switzerland), UV-Vis spectrophotometer (Shimadzu Corporation, UV-2401PC, China), sonicator, mortar and pestle, different glass wares were used throughout the experimental work. Ciprofloxacin 500 mg film coated tablets, Pharmaceutical grade (reference standards) Ciprofloxacin HCl chemical and Distilled water was used as solvent. Methods: The maximum wavelength was taken at which the RS solution showed maximum absorption/peak. The method was validated before according to ICH/USP guidelines for method validation parameters. Quantification was done at selected wavelength using Beer’s Law. Results and Discussion: The maximum wavelength (λ max) of the drug was obtained at 275 nm. The amount of Ciprofloxacin at the selected maximum wave length was found to be 97.93% of the labeled claim. The percent interference for the placebo was found to be 1.59%. The result reveals that there is a strong linear relationship between the concentration of the test sample and the absorbance values over the concentration range 3 to 7 μg/ml of Ciprofloxacin. With a regression equation Y = 0.105X -0.0035 and; r2 = 0.9994. The percent mean recovery obtained was between 98 - 102%.
Keywords
Spectrophotometr, Ciprofloxaciline, Method Validation, Quantification
Reference
| [01] | BP (British Pharmacopoeia). (2009) The Pharmaceutical Press, Her Majesty’s Stationery Office, London, Vol. I and II. |
| [02] | Chung Ch, Ch. Herman, L. Lee Y,C and Zhang, X. (2004) Analytical method validation and instrument performance verification, John Wiley & Sons, Inc., Hoboken, Publication, New Jersey. |
| [03] | FDA. (2001) Guidance for Industry: Bioanalytical Method Validation, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). |
| [04] | Frank A, S. (1997). Hand book of instrumental techniques for analytical chemistry, Prentice Hall, Inc. A Simon & Schuster Company, New Jersey. |
| [05] | International Conference on Harmonization (ICH). (2005) Validation of Analytical Procedures, Text and Methodology, Q2 (R1). |
| [06] | Kassab N M, Singh A K, Kedor-Hackmam E R M, and Santoro M I R M. (2005) Quantitative determination of ciprofloxacin and norfloxacin in pharmaceutical preparations by high performance liquid chromatography. Brazilian Journal of Pharmaceutical Sciences 41:4. |
| [07] | Swartz M. (2009) Developing and Validating Dissolution Procedures for Improved Product Quality, synomics pharm, www.synomicspharma.com |
| [08] | USP (The United States Pharmacopoeia). (2008) USP31/NF26, Rockville, Vol.1, MD, USA. |
| [09] | World Health Organization (WHO). (2006) Supplementary guidelines on good manufacturing practices: validation; WHO Technical Report Series, No. 937, 2006. |
| [10] | Nájla M. K., Anil K. S., Erika R. M. K-H. and Maria I. R. M. S.. Brazilian Journal of Pharmaceutical Sciences vol. 41, n. 4, out./dez., 2005. |
| [11] | Pandey S., Pandey P., Tiwari G., Tiwari R. and Rai A. K.. FTIR Spectroscopy: A Tool for Quantitative Analysis of Ciprofloxacin In Pharmaceutical Formulations |
