DEVELOPMENT AND VALIDATION OF A SIMPLE UV-SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF CIPROFLOXACIN HCL PRESENT IN TASTE MASKED DRUG RESIN COMPLEX
Keywords:UV spectroscopy, Validation, Analytical Method Development, Ciprofloxacin HCl, Indion 414, Indion 254, Drug resin complex, Resinate, 01 N HCl
Objective: The objective of this study was to develop and validate a novel, specific, precise and simple UV-spectrophotometric method for the estimation of ciprofloxacin HCl present in taste-masked drug-resin complex.
Methods: UV-spectrophotometric determination was performed with ELICO SL 1500 UV-Vis spectrophotometer using 0.1 N HCl as a medium. The spectrum of the standard solution was run from 200-400 nm range for the determination of absorption maximum (Î» max). Î» max of ciprofloxacin HCl was found at 276 nm. The absorbance of standard solutions of 1, 2, 3, 4, 5 and 6 Âµg/ml of drug solution was measured at an absorption maximum at 276 nm against the blank. Then a graph was plotted by taking concentration on X-axis and absorbance on Y-axis which gave a straight line. Validation parameters such as linearity and range, selectivity and specificity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness were evaluated as per ICH guidelines.
Results: Linearity for the UV-spectrophotometric method was noted over a concentration range of 1-6 Âµg/ml with a correlation coefficient of 0.9995. The limit of detection (LOD) and limit of quantification (LOQ) for ciprofloxacin HCl was found at 0.46 Î¼g/ml and 1.38 Î¼g/ml respectively. Accuracy was in between 98.89 and 99.27%. % RSD for repeatability, intraday precision and interday precision were found to be 1.271, in between 0.351 and 0.659 and in between 1.067 and 1.769 respectively. The proposed UV spectrophotometric method is found to be robust.
Conclusion: The proposed UV-spectrophotometric method was validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed method is sensitive, precise, reliable and simple for the estimation of ciprofloxacin HCl present in taste-masked drug-resin complex.
Zhanel G, Fontaine S, Adam H, Schurek K, Mayer M, Noreddin AM, et al. A review of new fluoroquinolones: focus on their use in respiratory tract infections. Treat Respir Med 2006;6:437-65.
Ball P. Quinolone generations: natural history or natural selection. J Antimicrob Chemother 2000;46:17-24.
Oliphant CM, Green GM. Quinolones: a comprehensive review. Am Fam Physician 2002;3:455-64.
https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=16099. [Last accessed on 10 Nov 2017]
http://www.medicines.org.au/files/gxpcipro.pdf. [Last accessed on 10 Nov 2017]
Drlica K, Zhao X. DNA gyrase, topoisomerase IV, and the 4-quinolones. Microbiol Mol Biol Rev 1997;3:377-92.
Bhutta ZA. Current concepts in the diagnosis and treatment of typhoid fever. Br Med J 2006;333:78-82.
DuPont HL, Ericsson CD. Prevention and treatment of traveller's diarrhea. N Engl J Med 1993;328:1821-6.
Z Vybiralova, M Nobilis, J Zoulova, J Kvetina, P Petr. High-performance liquid chromatographic determination of ciprofloxacin in plasma samples. J Pharm Biomed Anal 2005;5:851-8.
Sani A Ali, Chijioke C Mmuo, Rafat O Abdulraheem, Sikirat S Abdulkareem, Emmanuel T Alemika, Musa A Sani, et al. High-performance liquid chromatography (HPLC) method development and validation indicating assay for ciprofloxacin hydrochloride. J Appl Pharm Sci 2011;8:239-43.
Lacroix PM, Curran NM, Sears RW. High-pressure liquid chromatographic methods for ciprofloxacin hydrochloride and related compounds in raw materials. J Pharm Biomed Anal 1996;5:641-54.
Ranjit Singh, Mukesh Maithani, Shailendra K Saraf, Shubhini Saraf, Ram C Gupta. Simultaneous estimation of ciprofloxacin hydrochloride, ofloxacin, tinidazole and ornidazole by reverse phase-high performance liquid chromatography. Eurasian J Anal Chem 2009;2:161-7.
B Aksoy, I KuÃ§ukguzel, S Rollas. Development and validation of a stability indicating HPLC Method for determination of ciprofloxacin hydrochloride and its related compounds in film-coated tablets. Chromatographia 2007;1:57-63.
Vania Maslarska, Boyka Tsvetkova, Lily Peikova, Bistra Kostova, Dimitar Rachev Stanislav Bozhanov, Nelina Zareva. HPLC assay of model tablet formulations containing metronidazole and ciprofloxacin. Int J Pharm Pharm Sci 2016;5:306-10.
Amina Mohamed El Brashy, Mohamed El Sayed Metwally, Fawzi Abdallah El Sepai. Spectrophotometric determination of some fluoroquinolone antibacterials by binary complex formation with xanthenes dyes. Farmaco 2004;10:809-17.
Sanghavi NM. Ion-exchange resins as matrices for controlled drug release. Indian Drugs 1988;26:27-32.
Validation of analytical procedures: Text and methodology. International Conference on Harmonization (ICH) Q2 (R1) guideline. Geneva, Switzerland; 2005.