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Innovative Spectrophotometric Methods for Determination of Newly Discovered Combination for Hepatitis C Treatment

Innovative Spectrophotometric Methods for Determination of Newly Discovered Combination for... AbstractLedipasvir (LED) and Sofosbuvir (SOF) are newly approved antiviral agents co-formulated for treatment of hepatitis C virus (HCV). Up till now, no analytical methods have been published for determination of this pharmaceutically important combination. In this work novel spectrophotometric methods were developed for resolving the partially overlapped spectra of LED and SOF with simple data manipulation and without preliminary separation steps. In method (I), LED was directly determined using its extended spectra at 325 nm where no interference from the co-formulated SOF while the absorption at the isoabsorptive point (λ= 262.4 nm) was used for measuring concentrations of both. By subtraction, concentration of SOF could be obtained. Method (II) is the absorbance subtraction method (AS) at which a mathematically estimated factor representing the absorbance ratio (A262.4 /A325 ) for pure LED was used for simultaneous quantitation of LED and SOF using a unique equation computed at λiso (262.4 n m). Method (III) depended on using ratio spectra and then measuring the amplitude of the constant at 325 nm for LED while using ratio subtraction spectrophotometric method to quantify SOF at 262 nm. Finally, method (IV) was area under the curve correction method (AUCC) at which the areas from 245-265 and 315-335 nm and a mathematically calculated factor for pure LED were used. The methods were validated in compliance to USP guidelines and were successfully applied to available dosage form. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Innovative Spectrophotometric Methods for Determination of Newly Discovered Combination for Hepatitis C Treatment

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Innovative Spectrophotometric Methods for Determination of Newly Discovered Combination for Hepatitis C Treatment

Abstract

AbstractLedipasvir (LED) and Sofosbuvir (SOF) are newly approved antiviral agents co-formulated for treatment of hepatitis C virus (HCV). Up till now, no analytical methods have been published for determination of this pharmaceutically important combination. In this work novel spectrophotometric methods were developed for resolving the partially overlapped spectra of LED and SOF with simple data manipulation and without preliminary separation steps. In method (I), LED was directly determined...
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Publisher
Taylor & Francis
Copyright
© 2016 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2016.1265468
Publisher site
See Article on Publisher Site

Abstract

AbstractLedipasvir (LED) and Sofosbuvir (SOF) are newly approved antiviral agents co-formulated for treatment of hepatitis C virus (HCV). Up till now, no analytical methods have been published for determination of this pharmaceutically important combination. In this work novel spectrophotometric methods were developed for resolving the partially overlapped spectra of LED and SOF with simple data manipulation and without preliminary separation steps. In method (I), LED was directly determined using its extended spectra at 325 nm where no interference from the co-formulated SOF while the absorption at the isoabsorptive point (λ= 262.4 nm) was used for measuring concentrations of both. By subtraction, concentration of SOF could be obtained. Method (II) is the absorbance subtraction method (AS) at which a mathematically estimated factor representing the absorbance ratio (A262.4 /A325 ) for pure LED was used for simultaneous quantitation of LED and SOF using a unique equation computed at λiso (262.4 n m). Method (III) depended on using ratio spectra and then measuring the amplitude of the constant at 325 nm for LED while using ratio subtraction spectrophotometric method to quantify SOF at 262 nm. Finally, method (IV) was area under the curve correction method (AUCC) at which the areas from 245-265 and 315-335 nm and a mathematically calculated factor for pure LED were used. The methods were validated in compliance to USP guidelines and were successfully applied to available dosage form.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Nov 1, 2016

Keywords: Ledipasvir; Sofosbuvir; isoabsorptive; absorbance subtraction; area under the curve; amplitude of constant

References

  • Sofosbuvir: A novel treatment option for chronic hepatitis C infection
  • Development of a sensitive UPLC-ESI-MS/ MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: Application to a bioequivalence study
  • Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS
  • Simple spectrometric analysis of acebutolol hydrochloride and atenolol in combined pharmaceutical dosages with hydrochlorothiazide
  • Simple spectrometric analysis of propranolol hydrochloride and hydrochlorothiazide from combined pharmaceutical dosages
  • Smart stability indicating spectrophotometric methods for determination of binary mixtures without prior separation
  • Novel spectrophotometric methods for simultaneous determination of timolol and dorzolamide in their binary mixture
  • A comparative study of novel spectro-photometric methods basedon isosbestic points; application on a pharmaceutical ternary mixture
  • A comparative study of different aspects of manipulating ratio spectra applied for ternary mixtures: derivative spectrophotometry versus wavelet transform
  • Spectrophotometric determination of metronidazole, diloxanidefuroate and metronidazole toxic impurity
  • Validated spectrophotometric methods for simultaneous determination of omeprazole, tinidazole and doxycycline in their ternary mixture
  • Two spectrophotometric methods for simultaneous determination of some antihyperlipidemic drugs
  • A comparative study of novel spectrophotometric resolution techniques applied for pharmaceutical mixtures with partially or severely overlapped spectra
  • Different spectrophotometric and TLC-densitometric methods for determination of mesalazine in presence of its two toxic impurities
  • Superior spectrophotometric method for determination of a ternary mixture with overlapping spectra
  • Two different spectrophotometric determinations of potential anticancer drug and its toxic metabolite