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151 INTERNATIONAL JOURNAL OF INNOVATION IN ENGINEERING RESEARCH & MANAGEMENT ISSN: 2348-4918
Peer Reviewed and Refereed Journal
VOLUME: 08, Issue 04, Paper id-IJIERM-VIII-IV, August 2021
UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTIFICATION OF CEFIXIME AND LINEZOLID IN
COMBINED DOSAGE FORM
Anumula Narender Reddy
Asst. Professor, Department of Pharmaceutics, Princeton College of Pharmacy, Hyderabad, Telangana, India
A Mallikarjun
Asst. Professor, Department of Pharmaceutics, Princeton College of Pharmacy, Hyderabad, Telangana, India
Abstract - Linezolid (LIN) belongs to the oxazolidinone class of antibiotics, while cefixime (CEF) belongs to the cephalosporin class. Numerous bacterial diseases can benefit from this drug combination. For the simultaneous estimation of Cefixime (CEF) and Linezolid (LIN) in tablet form, a method that is accurate, precise, quick, and inexpensive was developed. The method is based on simultaneous equations, and the wavelengths that were chosen for analysis in methanol were 289.0 nm (the maximum wavelength for cefixime) and 257.0 nm (the maximum wavelength for linezolid). Cefixime was found to be linear at concentrations of 5-40 g/ml, whereas Linezolid was found to be linear at concentrations of 10-30 g/ml. The relationship coefficient of Cefixime and Linezolid were viewed as 0.9998 and 0.9998 separately.
The proposed strategy was effectively applied for the concurrent assurance of the two medications in business tablet readiness. The aftereffects of the investigation have been approved measurably and by recuperation studies have affirmed the exactness of proposed technique.
Keywords: Simultaneous equations, Cefixime (CEF), Linezolid (LIN), and the Ultra- Violet Spectrometric method.
1 INTRODUCTION
Cefixime (CEF) is an antibiotic taken orally of the third generation of cephalosporins. Chemically, it is (6R, 7R)-7-[2-(2-amino-1,3-thiazol-4-yl)-2 (carboxymethoxy-imino)acetyl]amino- 3-ethenyl-8-oxo-5-thia-1 azabicyclo- [4.2.0]oct-2-ene-2 carboxylic acid1,3.
Clinically, it is used to treat infections that are susceptible to infection, such as gon The first antibiotic in the oxazolidinone class is Linezolid (LIN), which is also useful as an antibacterial agent2,3. Chemically, Linezolid is N-[(5S)-3-[3-fluoro- 4- (morpholin-4-yl)phenyl]-2-oxo-1,3- oxazolidin-5-yl]methylacetamide.
In the form of a combined dose tablet containing 200:600 mg CEF, both drugs are sold: LIN. According to the literature review, Linezolid can be estimated using spectrophoto- metrically22, HPLC1, 19, and HPTLC18 alone or in combination with other drugs in bulk drugs and human plasma. Cefixime can also be
estimated using
spectrophotometrically4-13 and HPLC13-17. However, no analytical method has been reported for estimating CEF and LIN in a formulation with a combined dosage.
The Simultaneous equation method for the simultaneous estimation of
=
152 INTERNATIONAL JOURNAL OF INNOVATION IN ENGINEERING RESEARCH & MANAGEMENT ISSN: 2348-4918
Peer Reviewed and Refereed Journal
VOLUME: 08, Issue 04, Paper id-IJIERM-VIII-IV, August 2021 CEF and LIN in tablet formulation is
described in this work.
2 MATERIALS AND METHODS 2.1 Instrument
A double-beam Shimadzu-1800 UV- visible spectrophotometer with a wavelength accuracy of less than 0.5 nm and a spectral bandwidth of 2 nm.
It also measures the solution's absorbance in pairs.
2.2 Materials
Mepro Pharmaceuticals Ltd., Dholka, and Cadila Healthcare Pvt. provided the standard Cefixime and Linezolid samples that were included in the gift.
Dabhasa, L. Tablets containing Cefixime and Linezolid in one dose were obtained from the local market.
As a solvent, Loba Chemie, Mumbai, provided AR-grade methanol.
2.3 Stock Solutions
Stock solution The methanol-prepared standard stock solutions of CEF (100 g/ml) and AZI (100 g/ml) were utilized for the analysis.
2.4 Spectral Characteristics of CEF and LIN
A proper dilution of the standard stock solution was used to prepare the separate solutions of CEF and LIN (10 g/ml each). From 400 nm to 200 nm, both solutions were scanned in spectrum mode (fig. 1, 2).
2.5 Preparation of Calibration Curves
To obtain 1, 5, 10, 20, 30, and 40 g/ml of CEF and LIN, separate
dilutions of the standard stock solution were performed. All of the solutions' absorption spectra were measured between 200 and 400 nm.
At 289.0 nm (the maximum of CEF) and 257.0 nm (the maximum of LIN), the absorbances were measured.
Working calibration curves for both CEF and LIN were plotted separately within the Beer's lamberts range.
An easy-to-use and accurate method for analyzing CEF and LIN simultaneously is presented in this work. The maximum wavelengths for analysis using the simultaneous equation method were 289.0 nm for Cefixime and 257.0 nm for Linezolid.
Linearity in the detector response was observed in the concentration range of 10 to 30 g/ml for LIN and 10 to 40 g/ml for CEF using this method. For the purpose of determining the concentrations of CEF and LIN in tablet sample solution, absorptivities were calculated for both drugs at selected wavelengths and substituted into equations. In tablet analysis, this method revealed 99.03 percent label claim for CEF and 98.78 percent label claim for LIN. Low LOD and LOQ values indicated the proposed method's high sensitivity. Recovery studies verified the accuracy of the proposed methods. Using this approach, the percentages of recovery for CEF and LIN were found to be 100.51% and 100.23%, respectively.
For routine quality control of Cefixime and Linezolid in combined dose tablet formulation, the proposed method could be used.
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153 INTERNATIONAL JOURNAL OF INNOVATION IN ENGINEERING RESEARCH & MANAGEMENT ISSN: 2348-4918
Peer Reviewed and Refereed Journal
VOLUME: 08, Issue 04, Paper id-IJIERM-VIII-IV, August 2021 Figure 1 UV-Spectra of Cefixime (10μg/ml)
Figure 2 UV-Spectra of Linezolid (10μg/ml)
3 CONCLUSION
The developed methods were found to be within the specified limit after being validated in accordance with ICH guidelines. It comes to the conclusion that the developed methods are user-friendly, precise, sensitive, and suitable for both the real-world and tablet dosage forms.
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