Asian Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

RP-HPLC Method Development and Validation for Estimation of Sofosbuvir in Pure and Tablet Dosage Form


Affiliations
1 Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
     

   Subscribe/Renew Journal


A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validation of Sofosbuvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×150mm, 5μ) column using a mixture of Methanol (100% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 265 nm. The retention time of the Sofosbuvir was 3.515 ±0.02min. The method produce linear responses in the concentration range of 20-100μg/mL of Sofosbuvir. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords

Sofosbuvir, RP-HPLC, Validation, Tablet Dosage Forms.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Andrea Weston and Phyllisr.Brown, HPLC Principle and Practice ,1st edition Academic press, (1997), PP 24-37.

  • Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publicat ion, (2007), PP 15-23.

  • Chromatography, (online). URL:http://en.wikipedia.org/wiki/Chromatography.

  • Meyer V.R. Practical High-Performance Liquid Chromatography, 4th Edn. England, John Wiley & Sons Ltd, (2004), PP 7-8.

  • Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.

  • Introduction to Column. (Online),URL:http://amitpatel745.topcities.com/index_files/study/column care.

  • Detectors used in HPLC (online )URL:http://wiki.answers.com/Q/What_detectors_are_used_in_HPLC

  • Detectors (online) ,URL:http://hplc.chem.shu.edu/NEW/HPLC_Book/Detectors.

  • Detectors (online) ,URL:http://www.dionex.com/enus/webdocs/64842-31644-02_PDA-100.

  • Detectors (online),URL:http://www.ncbi.nlm.nih.gov/pubmed/8867705

  • Detectors (online),URL:http://www.chem.agilent.com/Library/applications/59643559.

  • Draft ICH Guidelines on Validation of Analytical Procedures Definitions and terminology. Federal Register, vol 60. IFPMA, Switzerland, (1995), PP 1126.

  • Code Q2B, Validation of Analytical Procedures; Methodology. ICH Harmonized Tripartite Guidelines, Geneva, Switzerland, (1996), PP 1- 8.


Abstract Views: 248

PDF Views: 0




  • RP-HPLC Method Development and Validation for Estimation of Sofosbuvir in Pure and Tablet Dosage Form

Abstract Views: 248  |  PDF Views: 0

Authors

P. Swathi
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
K. Rajeswar Dutt
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
K. N. V. Rao
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India
M. Alagar Raja
Nalanda College of Pharmacy, Charlapally, Nalgonda, Telangana, India

Abstract


A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validation of Sofosbuvir, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×150mm, 5μ) column using a mixture of Methanol (100% v/v) as the mobile phase at a flow rate of 1.0 mL/min, the detection was carried out at 265 nm. The retention time of the Sofosbuvir was 3.515 ±0.02min. The method produce linear responses in the concentration range of 20-100μg/mL of Sofosbuvir. The method precision for the determination of assay was below 2.0% RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords


Sofosbuvir, RP-HPLC, Validation, Tablet Dosage Forms.

References