SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF CEFUROXIME SODIUM AND SULBACTAM SODIUM IN INJECTON
HTML Full TextSPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF CEFUROXIME SODIUM AND SULBACTAM SODIUM IN INJECTON
F.M. Patel, J. B. Dave and C. N. Patel
Department of Quality Assurance, Shri Sarvajanik Pharmacy College, Mehsana-384001, Gujarat, India
ABSTRACT
Cefuroxime is a 2nd-generation cephalosporin and Sulbactam is a β-Lactamase inhibitor. The combination formulation is used for the treatment of lower respiratory tract infection. Two new, simple, accurate and precise UV spectrophotometric methods have been developed and validated for the simultaneous determination of Cefuroxime Sodium (CEF) and Sulbactam Sodium (SUL) in their combined dosage forms. First method is based on simultaneous estimation of Cefuroxime at 279nm and Sulbactam at 259 nm, while other Q‐absorption Ratio method using two wavelengths, 259nm (λmax of SUL) and 272nm (Isoabsorptive point). 0.01 N NaOH was the solvent used in all methods. Cefuroxime Sodium showed linearity in the range of 8-32μg/mL and Sulbactam sodium showed linearity in the range of 4-16μg/mL in all the methods. All methods were validated statistically and recovery studies were carried out. All methods were found to be accurate, precise and reproducible. These methods were applied to the assay of the drugs in marketed formulation, which were found in the range of 98.0% to 100.0% of the labelled value for both Cefuroxime and Sulbactam. Hence, the methods herein described can be successfully applied in quality control of combined pharmaceutical dosage forms.
Keywords:Cefuroxime Sodium,
Sulbactam Sodium, UV‐Spectrophotometric method, Simultaneous equation method, |
Q-absorbance ratio method
INTRODUCTION: Cefuroxime Sodium is Sodium(7R)-3-carbamoyloxymethyl-7-[(z)-furan-2-yl-2-methoxyimino acetamido]-3-cephem-4-carboxylate. Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillin) but are less susceptible to hydrolysis of β- Lactamase produced by microbes. Cephalosporins disrupt the synthesis of the peptodoglycan layer of bacterial cell walls 1, 2, 3.
Sulbactam sodium is Sodium(7R)-3-carbamoyl oxymethyl-7-[(z)-furan-2-yl-2-methoxyimino acetamide ]-3cephem-4-carboxylate. It is an irreversible inhibitor of beta-Lactamase; it binds the enzyme and does not allow it to interact with the antibiotic. Hydrolysis of the β-Lactam ring either by enzymatic cleavage with β- Lactamase or by acid destroys the antibacterial activity of β-lactam antibiotic. Certain molecules can inactivate b-Lactamase, thus preventing the destruction of b-lactam antibiotics 1, 2, 3, 8, 9, 10.
The chemical structures of CEF and SUL are shown in Fig. 1 (A) & (B).
FIG. 1: CHEMICAL STRUCTURE OF (A) CEFUROXIME SODIUM AND (B) SULBACTAM SODIUM 8, 9, 10
A detailed survey of analytical literature for CEF revealed several methods based on varied techniques, viz, HPLC 11, 12, 13, Spectrophotometery 14, 15, 16, Spectro-fluorimetry 17 and specific stability-indicating method by UV-Visible method 18. Similarly, a survey of the analytical literature for sul revealed several methods based on varied techniques, viz HPLC19, 20, 21, 22, Spectrophotometery 23, 24, 25, HPTLC 26.
According to, detailed survey of analytical literature none of the reported analytical procedures describes a simple and satisfactory UV spectrophotometric method for simultaneous determination of CEF and SUL in their combined dosage forms. So the objective of this work was to develop simple, precise and rapid spectrophotometric methods for combination drug products containing CEF and SUL.
MATERIALS AND METHODS:
Instrumentation: A Shimadzu model 1700(Japan) double beam UV/Visible spectrophotometer with spectral width of 2 nm, wavelength accuracy of 0.5 nm and a pair of 10 mm matched quartz cell was used to measure absorbance of all the solutions. Spectra were automatically obtained by UV-Probe system software (UV Probe version 2.31). An Electronic analytical balance (Acculab) and an ultrasonic bath were used in the study.
Materials and Reagents: CEF and SUL bulk powder was gifted by Zydus Cadila Health Care Pvt. Ltd., Ahmadabad, India and Bharat Parentral ltd., Ahmadabad, India respectively. The commercial fixed dose combination product was procured from the local market. NaOH Pallet AR Grade was procured from S.D.Fine Chemicals Ltd., Mumbai, India.
Standard and Test Solutions:
Preparation of Standard Solution: An accurately weighed quantity of CEF (10 mg) and SUL (10 mg) were transferred to a separate 100 ml volumetric flask and dissolved and diluted to the mark with 0.01 N NaOH to obtain standard solution having concentration of CEF (100μg/ml) and SUL (100μg/ml).
Preparation of Test Solution: From the Injection formulation, FASTGARD 2.25 (1500mg CEF & 750mg SUL), 30mg taken in 100 ml volumetric flask and the volume was adjusted to mark with 0.01 N NaOH. This was working sample solution having strength 200μg/ml of CEF & 100μg/ml of SUL.
Methods:
Simultaneous Equation Method: In this method, seven working standard solutions having concentration 8-32μg/ml for CEF and 4-16μg/ml for SUL were prepared in 0.01 N NaOH and the absorbance at 279 nm (λmax of CEF) and 259 nm (λmax of SUL) were measured and absorptivity coefficients
Were calculated using calibration curve.
The concentration of two drugs in the mixture can be calculated using following equations;
Article Information
88
3513-3517
636KB
2344
English
IJPSR
F.M. Patel, J. B. Dave and C. N. Patel
Department of Quality Assurance, Shri Sarvajanik Pharmacy College, Mehsana-384001, Gujarat, India
falgi86@yahoo.co.in
24 April, 2012
14 May, 2012
21 August, 2012
http://dx.doi.org/10.13040/IJPSR.0975-8232.3(9).3513-17
01 September, 2012