ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR DRUG PRODUCT BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD


Kalpana Nekkala, Shanmukha Kumar J V, Shanmukha Kumar J V, Shanmukha Kumar J V, Ramachandran D, Ramachandran D, Ramachandran D

Abstract


 Objectives: The purpose of the research is to develop a simple, precise, economical, accurate, reproducible, and sensitive method for the estimation of sofosbuvir and velpatasvir drug product by rp-hplc method

Methods: New Analytical method was developed for the estimation of Velpatasvir and Sofosbuvir in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Luna 18 150*4.6mm3.0um) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Formic acid in water: Methanol: Acetonitrile (35:40:25). The flow rate was 0.8ml/ minute and ultra violet detector at 269nm. The average retention time for Velpatasvir and Sofosbuvir found to be 2.62 min and 3.72 min.

Results: The developed method was validated as per the ICH analytical method validation guidelines. All validation parameters were within the acceptable range. The assay methods were found to be linear from 80-240 µg/ml for Sofosbuvir and 20-60µg/ml for Velpatasvir. The correlation coefficient was 0.9998 and 0.9992 for velpatasvir and sofosbuvir respectively.  The mean percentage recovery for the developed method was found to be in the range of 98.4-100.4% for velpatasvir and 98.6-100.6% for sofosbuvir. The developed method was also found to be robust

Conclusion: The developed method was found to be suitable for the routine quantitative analysis of Velpatasvir and Sofosbuvir in bulk and pharmaceutical dosage form. It was also concluded that developed method was accurate, precise, linear, reproducible, robust, and sensitive. 


Keywords


Sofosbuvir, Velpatasvir, Isocratic, High performance liquid chromatography, C18, Formic acid, Methanol.

| PDF |

References


ICH. Q2A Validation of Analytical Procedure: Methodology International Conference on Harmonization. Geneva: ICH; 1994.

Chakravarthy A, Bbv S, Kumar P. Method development and validation of ultraviolet-visible spectroscopic method for the estimation of hepatitis-c drugs-daclatasvir and sofosbuvir in active pharmaceutical ingredient form. Asian J Pharm Clin Res 2016;9:61-6.

Zaman B, Siddique F, Hassan W. RP-HPLC method for simultaneous determination of sofosbuvir and ledipasvir in tablet dosage form and its application to in vitro dissolution studies. Chromatographia 2016;79:1605-13.

Hassouna EM, Abdelrahman MM, Mohamed MA. Assay and dissolution methods development and validation for simultaneous determination of sofosbuvir and ledipasvir by RP-HPLC method in tablet dosage forms. J Forensic Sci Crim Invest 2017;1:505-9.

Devilal J, Durgaprasa B, Narottam P, Srinivasa A. New method development and validation for the determination of ledipasvir in bulk drug form by using reverse phase HPLC technique. World J Pharm Pharm Sci 2016;5:1312-21.

Nagaraju T, Vardhan SV, Kumar DR, Ramachandran D. A new RP-HPLC method for the simultaneous assay of SOFOSBUVIR and ledipasvir in combined dosage form. Int J Chemtech Res 2017;10:761-8.

Rezk MR, Basalious EB, Karim IA. Development of a sensitive UPLC-ESIMS/MS method for quantification of SOFOSBUVIR and its metabolite, GS-331007, in human plasma: Application to a bioequivalence study. J Pharm Biomed Anal 2015;114:97-104.

Madhavi S, Prameelarani A. Bioanalytical method development and validation for the determination of SOFOSBUVIR from human plasma. Int J Pharm Pharm Sci 2017;9:35-41.

Ravichandran V, Shalini S, Sundaram KM, Rajak H. Validation of analytical methods-strategies and importance. Int J Pharm Pharm Sci 2010;2:18-22.

Vejendla R, Subramanyam CV, Veerabhadram G. Estimation, and validation of SOFOSBUVIR in bulk and tablet dosage form by RP-HPLC. Int J Pharm 2016;6:121-7.

Pan C, Chen Y, Chen W, Zhou G, Jin L, Zheng Y, et al. Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci 2016;1008:255-9.

ICH. Harmonized Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology in Proceedings of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; 2005.

United States Food and Drug Administration. Guidance for Industry: Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. Rockville, MD: Draft Guidance USFDA; 2001.

Shi X, Zhu D, Lou J, Zhu B, Hu AR, Gan D. Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci 2015;1002:353-7.

Bunchorntavakul C, Reddy KR. Review article: The efficacy and safety of daclatasvir in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther 2015;42:258-72.

Sundaram V, Kowdley KV. Dual daclatasvir and sofosbuvir for treatment of genotype 3 chronic hepatitis C virus infection. Expert Rev Gastroenterol Hepatol 2016;10:13-20.

Patel MM, Patel HD. Development and validation of RP-HPLC method for simultaneous estimation of terbinafine hydrochloride and mometasone furoate in combined dosage form. Int J Pharm Pharm Sci 2014;6:106-9.




About this article

Title

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND VELPATASVIR DRUG PRODUCT BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

Keywords

Sofosbuvir, Velpatasvir, Isocratic, High performance liquid chromatography, C18, Formic acid, Methanol.

DOI

10.22159/ajpcr.2018.v11i2.22465

Date

01-02-2018

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 11 Issue 2 February 2018 Page: 164-168

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

62 Views | 73 Downloads

Authors & Affiliations

Kalpana Nekkala
Department of Chemistry, KL University, Vaddeswaram, Guntur, Andhra Pradesh, India.
India

Shanmukha Kumar J V
Department of Chemistry, KL University, Vaddeswaram, Guntur, Andhra Pradesh, India.
India

Shanmukha Kumar J V
Department of Chemistry, KL University, Vaddeswaram, Guntur, Andhra Pradesh, India.
India

Shanmukha Kumar J V
Department of Chemistry, KL University, Vaddeswaram, Guntur, Andhra Pradesh, India.
India

Ramachandran D
Department of Chemistry, KL University, Vaddeswaram, Guntur, Andhra Pradesh, India.
India

Ramachandran D
Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur, Andhra Pradesh, India.
India

Ramachandran D
Department of Chemistry, KL University, Vaddeswaram, Guntur, Andhra Pradesh, India.
India


Article Tools


Email this article (Login required)
Email the author (Login required)

Refbacks

  • There are currently no refbacks.