Development and Validation of RP-HPLC Method for the estimation of Sofosbuvir and Ledipasvir in combined dosage form
Article Sidebar
-
Ledipasvir, method development, Sofosbuvir, validation
Abstract
Nowadays scientists aim at developing generic and specific methods for drugs in combined pharmaceutical dosage forms. The main aim was to develop and carry out validation using precision and accuracy for Sofosbuvir and Ledipasvir by applying RP-HPLC method. The dosage form in fixed combination of Sofosbuvir-Ledipasvir helps in effective treatment of genotypes of chronic hepatitis C virus. This combination of Sofosbuvir-Ledipasvir was the first FDA approved direct acting antiviral to treat hepatitis C. Both the drugs were optimized using mobile phase as acetonitrile: 0.1% orthophosphoric acid (55:50v/v) with pH 3.0. The mobile phase was optimized at maximum wavelength of 283nm. The separation was achieved using C18 Cosmosil (4.6 x 250mm) column with a particle size of 5µ. The method was specific eluting retention times of 3.7 for Sofosbuvir and 6.0 for Ledipasvir. Intra and interday precision was carried and %RSD was found to be less than 2%. The results were found to be accurate with percentage recovery of 99.76% and 99.10% for Sofosbuvir and Ledipasvir respectively. Linearity was carried out in the concentration ranging from 40-200µg/mL and 9-45µg/mL for Sofosbuvir and Ledipasvir respectively. Both the drugs showed the regression coefficient of 0.999. Deliberate changes in flow rate, pH and wavelength were made and found that method was robust. The developed method was found to be accurate, simple, specific, robust and precise for the simultaneous estimation of Sofosbuvir and Ledipasvir in tablet dosage form.
Full text article
References
Devilal, J., Durgaprasad, B., et al. 2016. New method development and validation for the determination of ledipasvir in bulk drug form by using reverse phase HPLC technique. World Journal of Pharmacy and Pharmaceutical Science, 5(8):1312–1321.
Hassouna, M. E.-K. M., et al. 2017a. Assay and Dissolution Methods Development and Validation for Simultaneous Determination of Sofosbuvir and Ledipasvir by RP-HPLC Method in Tablet Dosage Forms. Journal of Forensic Sciences & Criminal Investigation, 1(3):555–562.
Hassouna, M. E.-K. M., et al. 2017b. Assay and Dissolution Methods Development and Validation for Simultaneous Determination of Sofosbuvir and Ledipasvir by RP-HPLC Method in Tablet Dosage Forms. Journal of Forensic Sciences & Criminal Investigation, 1(3):1–11.
Madhavi, S., Rani, A. P. 2017. Bioanalytical method development and validation for the determination of sofosbuvir from human plasma. International Journal of Pharmacy and Pharmaceutical Sciences, 9(3):35–35.
Naazneen, S., Sridevi, A. 2017. Development of assay method and forced degradation study of valsartan and sacubitril by RP-HPLC in tablet formulation. Int J App Pharm, 9(1):9–15.
Nagaraju, T., Vardhan, S. V. M., et al. 2017. A new RP-HPLC method for the simultaneous assay of sofosbuvir and ledipasvir in combined dosage form. International Journal of ChemTech Research, 10(7):761–768.
Rai, S. Y., Prajapati, Y., Patni, P. 2017. Development and validation of RPHPLC and UV spectroscopy methods for simultaneous estimation of Sofosbuvir and Ledipasvir in their combined tablet dosage form. Pharma Science Monitor, 8(2):369–388.
Ramesh, G., Madhukar, A., Kannappan, N., Ravinder, A., Sravanthi, K. 2016. Analytical method development and validation of Sofosbuvir tablets by RP- HPLC. J Pharm Res, 5:161–164.
Rao, B. S., Reddy, M. V., Rao, B. S. 2017. Simultaneous analysis of ledipasvir and sofosbuvir in bulk and tablet dosage form by stability indicating high performance liquid chromatographic method. Global Journal for Research Analysis, 6(4):505–509.
Ravichandran, V., Shalini, S., et al. 2010. Validation of analytical methods-strategies & importance. International Journal of Pharmacy and Pharmaceutical Sciences, 2(3):18–22.
Rote, A. P., Alhat, J., et al. 2017. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and Pharmaceutical Dosage Form. International Journal of Pharmaceutical Sciences and Drug Research, 9(06):291–299.
Trivedi, R. N., Tandel, J. N., et al. 2018. Chemometrically assisted RP-HPLC and spectroscopic method development for simultaneous multi-component analysis of Ledipasvir and Sofosbuvir in pure and pharmaceutical formulation. Der Pharmacia Lettre, 10(3):62–75.
Vejendla, R., Subramanyam, C. V. S., Veerabhadram, G. 2016. Estimation and validation of sofosbuvir in bulk and tablet dosage form by RP-HPLC. International journal of pharmacy, 6(2):121–127.
Vikas, P. M., Satyanarayana, T., et al. 2016. Development and validation of new RP-HPLC method for the determination of sofosbuvir in pure form. World Journal of pharmacy and pharmaceutical Sciences, 5(5):775–781.
Authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.