Simultaneous High-Performance Liquid Chromatographic Determination of Nitazoxanide and Ofloxacin in Tablet Formulation
 
More details
Hide details
1
Department of Chemical Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad 431004, MS, India
2
Wockhardt Research Centre, Aurangabad-431210 (MS), India
Publication date: 2017-10-07
 
Eurasian J Anal Chem 2009;4(3):304–313
 
KEYWORDS
ABSTRACT
A simple, rapid, and precise method was developed for the quantitative simultaneous determination of nitazoxanide and ofloxacin in new tablet formulation. Chromatographic separation of the two drugs was achieved on an Ymc pack-AM C18, 25-cm analytical column using mobile phase consisting of 10 mM dipotassium hydrogen phosphate:acetonitrile (65:35, v/v) finally the pH of the mobile phase was adjusted to 7.0 using o- phosphoric acid. The instrumental settings are flow rate of 1 mL min-1, column temperature at 30oC, and detector wavelength of 254 nm. The internal standard method was used for the quantification. Caffeine was used as an internal standard. The method validated for linearity, accuracy, precision, limit of detection, limit of quantification and robustness. The calibration curve shows excellent linearity over the concentration ranges of ofloxacin and nitazoxanide 20-200 µg mL-1 and 8-80 µg mL-1, respectively. The separation was completed less than 6 minutes. The proposed method can be used for the quality control of formulation products.
 
REFERENCES (13)
1.
Guerrant R L, Hughes J M, and Lima N l, (2005) New antiparasitic and anti-infective agents. Clin Infect Dis 40: 1173- 1180.
 
2.
Kapse GK, Prabhakar G and Raju S. (2006) Spectrophotometric methods for the estimation of nitazoxanide in pharmaceutical combination. Ind J Pharma Sci 68: 403- 406.
 
3.
Broekhuysen J, Stockis A,Lins RL, Graeve J.De and Rossignol J.F. (2000) Nitazoxanide pharmacokinetics and metabolism in man. Int J Clin Pharmacol Ther 38: 387-394.
 
4.
Rane VP, Patil KR, Sangshetti JN, Yeole RD and Shinde DB (2008) Stabilityindicating LC determination of nitazoxanide in bulk drug and pharmaceutical dosage form. Chromatographia 67: 455-459.
 
5.
Gopu CL, Thomus S, Pradkar AR and Mahadik KR (2007) Stability indicating HPTLC method for the determination of nitazoxanide in pharmaceutical dosage form. J Sci Ind Res 66 (2): 141-145.
 
6.
Fabre D,Bressolle F, Kinowski JM, Bouvet O, Paganin F and. Galtier M(1994) A reproducible, simple and sensitive HPLC assay for the determination of ofloxacin in plasma and lung tissue. J Pharma Biomed Anal 12: 1463-1469.
 
7.
Samanidou VF, Demetriou CE and. Papadoyannis IN(2003) Direct determination of four fluoroquinolones, enoxacin, norfloxacin, ofloxacin and ciprofloxacin in pharmaceuticals and blood serum by HPLC. Anal Bio AnalChem 375: 623-629.
 
8.
Spell JC and. Stewart JT (1999) HPLC analysis of meropenem-ofloxacin mixture in intravenous solution using a nonporous octadecylsilane column. Liq Chromtogr Relat Technol 22: 2225-2234.
 
9.
Ali MS,Ghori M and Saeed (2002)A Simultaneous determination of ofloxacin, tetrahydrozoline hydrochloride and prednisolone acetate by high-performance liquid chromatography. J Chromatogr Sci 40: 429-433.
 
10.
Zivanovic LJ,Zigic G, and Zecevic M(2006)Investigation of chromatographic conditions for the separation of ofloxacin and its degradation products. J Chromatogr A 30: 224-230.
 
11.
Natarajan S, and Raman B. (2005) Development and validation of stability indicating HPLCmethod for the simultaneous estimation of ofloxacin and ornidazole. Indian Pharma 4: 79-84.
 
12.
Shervington LA, Abba M, Hussain B, and Donnelly J (2006)The simultaneous separation and determination of five quinolones antibiotics reversed-phase HPLC: Application to stability studies on an ofloxacin tablets formulations. J Pharma Biomed Anal 40: 1040-1044 .
 
13.
Drug Information Branch (HFD-210) (1996). “Validation of analytical procedures: Methodology, step 4”. In ICH Harmonized Tripartite Guidelines Q2B. Centre for Drug Evaluation and Research, Rockville, MD.
 
eISSN:1306-3057