Development and Validation of Green Method for Assessment of Clarithromycin in Pharmaceutical Formulation by Transmission Fourier Transform Infrared Spectroscopy
Date
2011-06-01
Authors
Muhammad Ali Mallah
S. T. H. Sherazi
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
<p>Clarithromycin is a semi-synthetic broad spectrum macrolide antibiotic widely used for theeradication of respiratory tract infections including atypical pneumonias and soft tissueinfections. It is an important substitute for patients exhibiting penicillin sensitivity andallergy.The methods reported previously for the detection of clarithromycin have mainly used lengthysample preparation procedures involving liquid–liquid extraction or solid-phase extractionprior to chromatographic analysis and most of these methods suffer from long run times andrequire large sample volumes. Although these methods offer selective detection ofclarithromycin but they are much more complex than the conventional ultraviolet (UV)detection. Clarithromycin has weak UV absorbance because it lacks a suitable chromophorewhich makes difficult to develop a specific, selective and sensitive method usingspectrophotometry without complexation and derivatization. As a impact of such laboratorypractice, large amounts of waste chemical are produced every day in industrial laboratorieswhich is of great concern throughout the world since long. So it becomes necessary to developalternative strategy which can substitute such traditional methods with clean andenvironmental friendly analytical means involving minimum consumption or replacement oftoxic reagents with the reagents having no or less polluting effects.A rapid, sensitive and environmental friendly analytical method for the direct determinationof clarithromycin in tablet formulations through transmission Fourier Transform Infrared(FT-IR) spectroscopy has been successfully developed for routine quality control analysis. Thismethod avoids any sample pretreatment except grinding or use of any solvent as extraction isno more required. Standards and samples were used in the form of KBr for recording FT-IRspectra. In the final step, chemometric method was used to filter out unmatched spectralfeatures and the converted and filtered spectra were used to build a calibration model basedon partial least square (PLS) using the FT-IR carbonyl region (C=O) from 2965-1662 cm−1.The excellent correlation coefficient (R2) was achieved (0.9999). This method gives maximumAnalytical Chemistry(IYC-2011) 79recovery of 102% and is fully validated. This also fulfills the ever increasing demand ofpharmaceutical industries for developing sensitive, economical, time consuming andenvironmental friendly analytical methods for the quantification of Active PharmaceuticalIngredients (API) while monitoring quality of finished product with total analysis time of lessthan three minutes.</p>
<p>Clarithromycin is a semi-synthetic broad spectrum macrolide antibiotic widely used for theeradication of respiratory tract infections including atypical pneumonias and soft tissueinfections. It is an important substitute for patients exhibiting penicillin sensitivity andallergy.The methods reported previously for the detection of clarithromycin have mainly used lengthysample preparation procedures involving liquid–liquid extraction or solid-phase extractionprior to chromatographic analysis and most of these methods suffer from long run times andrequire large sample volumes. Although these methods offer selective detection ofclarithromycin but they are much more complex than the conventional ultraviolet (UV)detection. Clarithromycin has weak UV absorbance because it lacks a suitable chromophorewhich makes difficult to develop a specific, selective and sensitive method usingspectrophotometry without complexation and derivatization. As a impact of such laboratorypractice, large amounts of waste chemical are produced every day in industrial laboratorieswhich is of great concern throughout the world since long. So it becomes necessary to developalternative strategy which can substitute such traditional methods with clean andenvironmental friendly analytical means involving minimum consumption or replacement oftoxic reagents with the reagents having no or less polluting effects.A rapid, sensitive and environmental friendly analytical method for the direct determinationof clarithromycin in tablet formulations through transmission Fourier Transform Infrared(FT-IR) spectroscopy has been successfully developed for routine quality control analysis. Thismethod avoids any sample pretreatment except grinding or use of any solvent as extraction isno more required. Standards and samples were used in the form of KBr for recording FT-IRspectra. In the final step, chemometric method was used to filter out unmatched spectralfeatures and the converted and filtered spectra were used to build a calibration model basedon partial least square (PLS) using the FT-IR carbonyl region (C=O) from 2965-1662 cm−1.The excellent correlation coefficient (R2) was achieved (0.9999). This method gives maximumAnalytical Chemistry(IYC-2011) 79recovery of 102% and is fully validated. This also fulfills the ever increasing demand ofpharmaceutical industries for developing sensitive, economical, time consuming andenvironmental friendly analytical methods for the quantification of Active PharmaceuticalIngredients (API) while monitoring quality of finished product with total analysis time of lessthan three minutes.</p>
<p>Clarithromycin is a semi-synthetic broad spectrum macrolide antibiotic widely used for theeradication of respiratory tract infections including atypical pneumonias and soft tissueinfections. It is an important substitute for patients exhibiting penicillin sensitivity andallergy.The methods reported previously for the detection of clarithromycin have mainly used lengthysample preparation procedures involving liquid–liquid extraction or solid-phase extractionprior to chromatographic analysis and most of these methods suffer from long run times andrequire large sample volumes. Although these methods offer selective detection ofclarithromycin but they are much more complex than the conventional ultraviolet (UV)detection. Clarithromycin has weak UV absorbance because it lacks a suitable chromophorewhich makes difficult to develop a specific, selective and sensitive method usingspectrophotometry without complexation and derivatization. As a impact of such laboratorypractice, large amounts of waste chemical are produced every day in industrial laboratorieswhich is of great concern throughout the world since long. So it becomes necessary to developalternative strategy which can substitute such traditional methods with clean andenvironmental friendly analytical means involving minimum consumption or replacement oftoxic reagents with the reagents having no or less polluting effects.A rapid, sensitive and environmental friendly analytical method for the direct determinationof clarithromycin in tablet formulations through transmission Fourier Transform Infrared(FT-IR) spectroscopy has been successfully developed for routine quality control analysis. Thismethod avoids any sample pretreatment except grinding or use of any solvent as extraction isno more required. Standards and samples were used in the form of KBr for recording FT-IRspectra. In the final step, chemometric method was used to filter out unmatched spectralfeatures and the converted and filtered spectra were used to build a calibration model basedon partial least square (PLS) using the FT-IR carbonyl region (C=O) from 2965-1662 cm−1.The excellent correlation coefficient (R2) was achieved (0.9999). This method gives maximumAnalytical Chemistry(IYC-2011) 79recovery of 102% and is fully validated. This also fulfills the ever increasing demand ofpharmaceutical industries for developing sensitive, economical, time consuming andenvironmental friendly analytical methods for the quantification of Active PharmaceuticalIngredients (API) while monitoring quality of finished product with total analysis time of lessthan three minutes.</p>