Spectrophotometric Estimation of Ofloxacin in Pharmaceutical Dosage Form
K. Navyatha*, P. Jyothi Kanaka Durga, B. Lakshmi Madhuri, K. Madhavi, N. Delhiraj
Department of Pharmaceutical Analysis, A.S.N Pharmacy College, Tenali, Andhra Pradesh.
*Corresponding Author E-mail: navya.kanneganti@gmail.com
ABSTRACT:
Simple, accurate and rapid Spectrophotometric method was developed for the estimation of ofloxacin in tablet dosage form. The method is based on the absorption of electromagnetic radiation by cefixime at the maximum wavelength at 294 nm in 0.1M Hydrochloric acid as solvent. Beer’s law was obeyed in the concentration range of 10-80 µg/ml. The percentage assay for commercial formulation was found to be 100.02± 0.82.Recovery value was found to be 99.95±0.54.
KEYWORDS: Ofloxacin, spectrophotometric methods, statistical analysis, recovery studies.
Ofloxacin is chemically (RS)9-fluoro-3-methyl-10-(4-methyl piperazin-1-yl)-7-oxo-2,3 dihydro-7H-pyrido[1,2,3-de]-1,4-benzoazeine-6-carboxylic acid. Ofloxacin is official in IP1. Literature survey revealed that various methods such as UV 2-5, HPLC 6-10, HPTLC 11 are available in single and combination with other drugs.
Figure 1: Structure
MATERIALS AND METHODS:
Instrumentation:
A Labindia UV/Visible spectrophotometer UV 3000+ series model with a Spectral band width of 10nm and wavelength accuracy of ±5nm with 1 cm matched quartz cells.
Chemicals:
Ofloxacin reference standard procured from Microlabs (Bangalore). Hydrochloric acid (Thermo Fisher Scientific India Pvt. Ltd, Mumbai) used for the analysis. All chemicals used of analytical grade. Commercial tablet formulation, Alproxen,(Alkem) containing 400mg of ofloxacin used for the estimation.
Preparation of 0.1M Hydrochloric acid:
8.5ml of concentrated Hydrochloric acid diluted to 1000ml distilled water.
Preparation of Standard Drug Solution:
The standard stock solution of ofloxacin (1mg/ml) was prepared by dissolving 100mg of drug in 0.1M Hydrochloric acid in 100ml of volumetric flask. The standard stock solutions were further diluted to get the concentration of 10-80µg/ml of the solutions were scanned between the range 200-400nm in 1 cm cell against blank and the overlain spectra was recorded (figure 2). The λmax of ofloxacin was 294nm.
Analysis of Tablet Formulation:
Twenty tablets were weighed and average weight was found. The tablets were triturated to a fine powder. An accurately weighed quantity of powder equivalent to 100 mg of was transferred in to 100 mL volumetric flask and added a minimum quantity of 0.1M Hydrochloric acid to dissolve the substance and made up to the volume with the same.
Table 1: OPTICAL PARAMETERS
|
lmax (nm) |
294 |
|
Beer’s law limits ( μg / ml) |
10-80 |
|
Molar absorptivity (L. mole-1 cm-1) |
3333.915 |
|
Regression equation (Y = a+ bc): |
|
|
Slope (b) |
0.013125 |
|
Standard deviation of slope (Sb) |
0.04770 |
|
Intercept (a) |
2.64038 |
|
Standard deviation of intercept (Sa) |
2.40886 |
|
Standard error of estimation (Se) |
0.19244 |
|
Correlation coefficient (r) |
0.9967 |
|
% Relative standard deviation* |
0.54432 |
*average for six determinations
Table 2: Analysis of pharmaceutical formulation
|
Pharmaceutical Formulation |
Labelled Amount (mg) |
Assay Found By Proposed Method (%) |
Recovery By Proposed Method (%) |
|
Alproxen |
400 |
100.02±0.82 |
99.95±0.54 |
The solution was sonicated for 15 minutes, centrifuged for another 15 minutes at 100 rpm and filtered through Whatman filter paper No. 41. From the clear solution, 0.8 ml was transferred to 10ml volumetric flask and dilute upto the volume. The absorbance of sample solution was measured at selected wavelengths. The content of ofloxacin in sample solutions of tablet was calculated by using calibration graph. This procedure was repeated for six times.
VALIDATION
Linearity:
For the linearity study, aliquots of the drug solutions were further diluted with 0.1M Hydrochloric acid to get the final working standards of concentration ranges as Ofloxacin (10-80µg/ml), Calibration curves were plotted between concentration and absorbance of drugs. Optical parameters were calculated.
Precision:
The precision of the method was confirmed by repeatability and intermediate precision. The repeatability was performed by the analysis of formulation was repeated for six times with the same concentration. The amount of each drug present in the tablet formulation was calculated. The % RSD was calculated.
Accuracy:
To check the accuracy of the developed method and to study the interference of formulation excipients, analytical recovery experiments were carried out by using standard addition method in three different concentrations. From the total amount of drug found, the percentage recovery was calculated. This procedure was repeated for three times for each concentration. The % RSD was calculated
RESULTS AND DISCUSSION:
An attempt has been made to develop a fast, precise, reproducible and economical analytical method for simultaneous estimation of ofloxacin in their combined dosage form. The drug obeys Beer’s law in the concentration range of 10-80 µg/ ml for Ofloxacin for the method. Sampling wavelengths based upon the direct UV spectroscopic data. There was no interference from tablet excipients was observed in this method. The optical parameter values such as % RSD and correlation of coefficient are reported in Table 1. The result of recovery studies for tablet is reported in Table 2. It indicates that there is no interference due to excipients present in the formulation. It can be easily and conveniently adopted for routine quality control analysis. Statistical analysis proves that, these methods are repeatable and selective for the analysis of ofloxacin.
CONCLUSION
A method was developed for the determination of tablets which is simple, quick, reliable, inexpensive and simple. The results indicate that the described method can be used for quantitative analysis of the compound.
ACKNOWLEDGEMENT
The authors are thankful to management of A.S.N Pharmacy College and Principal Dr. K. Venkata Ramana for encouragement and providing Support to carry out this research work.
REFERENCES
1. Indian pharmacopeia, Volume III , Govt of India, Ministry of Health and Family Welfare, Published by the controller of publication, New Delhi. 2007, 146
2. Senthilraja. M . Simultaneous UV spectrophotometric method for estimation of nitazoxanide and ofloxacin in combined dosage form. Ind. J. Pharm. Tech. 2008; 1:469-471.
3. Wankhede, S.B., Prakash A., Chitlange S.S. Simultaneous spectrophotometric method for estimation of ofloxacin and satranidazole in tablet dosage from” Asian J. Research Chem. 2008;1:9-11
4. Fegade, D., Mehta H. P., Chaudhari, R. Y., Patil V. R. Simultaneous spectrophotometric method for estimation of ofloxacin and ketorolac tromethamine in ophthalmic dosage forms. Int. J. Chem Tech Research. 2009; 1:189-194.
5. Mathur SC., Kumar Y., Murgesan N., Rathode YK.S, Sethi PD. Spectrophotometric determination of ofloxacin in pharmaceutical formulation. Indian Drugs. 1992; 29: 376-377.
6. Amini M,, Abdi K., Darabi M., Shafiee A. Determination of ofloxacin in plasma by HPLC with UV Detection. J. Appli, Sci. 2005; 5: 1655-1657
7. Chandhra I., Hemanth Kumar AK. Simple and rapid High performance liquid chromatography methods for the determination of ofloxacin concentration in plasma and urine. J. Chromatogar. B 2001; 760: 91 -95
8. Shinde S. R., Bhor S I., Pawar N. S.,Yadav S. B., Bhagawath A.M. . Simultaneous estimation of satranidazole and ofloxacin in tablet dosage form by high performance liquid chromatography. Journal of Chemistry. 2010; 7:198-202.
9. Garcia MA, Solan C, Calvo A, Royo M, Hernandej C, Rey R, Bregante MA. Analysis of ofloxacin in plasma samples by high performance liquid chromatography. Chromatographia. 2002; 55; (7-8): 431-434.
10. Dhandapani B, Thirumoorthi N, Rasheed SH, Kotaiah MH, Anjaneyalu N. Method development and validation for the simultaneous estimation of ofloxacin and orinidazole in tablet dosage form by RP-HPLC. International Journal on Pharmaceutical on Biomedical Research. 2010; 1(1):42-47.
11. Gandhimathi M., Ravi T. K., Shukla N. Validated high performance thin layer chromatography method for simultaneous estimation of ofloxacin and ornidazole in tablet dosage form. Ind. J. Pharm. Sci. 2006; 68:838-840.
Received on 30.11.2012 Modified on 14.12.2012
Accepted on 20.12.2012 © AJRC All right reserved
Asian J. Research Chem. 6(1): January 2013; Page 17-18