Development And Validation Of Three Novel UV Spectrophotometric Methods For Determination Of Newly Discovered Combination For The Treatment Of Hepatitis C And Their Comparison Using ANOVA

Authors

  • Mansuri Reema Department of Quality Assurance, Pioneer Pharmacy Degree College, Nr.Ajwa Crossing, Vadodara, Gujarat, India.
  • Patel Dhara Department of Quality Assurance, Pioneer Pharmacy Degree College, Nr.Ajwa Crossing, Vadodara, Gujarat, India.
  • Patel Khushboo Department of Quality Assurance, Pioneer Pharmacy Degree College, Nr.Ajwa Crossing, Vadodara, Gujarat, India
  • Meshram Dhananjay Department of Quality Assurance, Pioneer Pharmacy Degree College, Nr.Ajwa Crossing, Vadodara, Gujarat, India.

Keywords:

Sofosbuvir, Velpatasvir, First order derivative, Absorbance correction, Dual wavelength, Validation

Abstract

Sofosbuvir and Velpatasvir combination is used for hepatits C and newly introduce in market. It is necessary to develop suitable quality control methods for rapid and accurate determination of these drugs. Three simple, accurate, sensitive, precise and economical UV spectrophotometric methods (A, B & C) have been developed for simultaneous estimation of Sofosbuvir and Velpatasvir in pharmaceutical dosage form and their comparision using ANOVA. Method (A) is based on the first order derivative spectrophotometric method at zero crossing wavelength. In this method the zero crossing point of Sofosbuvir is 260 nm and for Velpatasvir is 250 nm. The linearity was obtained in the concentration range of 4-24µg/ml for Sofosbuvir and 1-6µg/ml for Velpatasvir using methanol as a solvent. Method (B) is based on principle of absorbance correction, it was performed at 260 nm for Sofosbuvir and at 302 nm for Velpatasvir. Method (C) is based on principle of dual wavelength method developed using absorbance difference at 250 nm and 268.26 nm for Sofosbuvir and 280 nm and 259.28 nm for Velpatasvir. The accuracy and precision of the methods were determined and validated statistically. All the methods showed good reproducibility and recovery with % RSD less than 2. The three methods were compared using one -way ANOVA and the fcal value was found to be less than ftab value indicating that there is no significant difference in the assay results by the three methods. All methods were found to be rapid, specific, precise and accurate and these methods require no preliminary separation and found no interferences from the tablet excipients so it can be used for routine analysis of both drugs in quality control laboratories.

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References

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Published

2018-03-18
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Mansuri Reema, Patel Dhara, Patel Khushboo, and Meshram Dhananjay. “Development And Validation Of Three Novel UV Spectrophotometric Methods For Determination Of Newly Discovered Combination For The Treatment Of Hepatitis C And Their Comparison Using ANOVA”. International Journal of Pharmaceutics and Drug Analysis, vol. 6, no. 3, Mar. 2018, pp. 391-9, https://ijpda.com/index.php/journal/article/view/381.

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