AN INNOVATIVE METHOD DEVELOPMENT AND FORCED DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR BY RP HPLC

  • B. Anjaneyulu Reddy Faculty of Science, Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India
  • Md. Irshad Alam Faculty of Science and Technology, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, India
  • Nazia Khanam Malla Reddy Institute of Pharmaceutical Sciences, Hyderabad, India
  • P. R. Adhakrishnanand Daicel Chiral Technologies, Hyderabad, India

Abstract

Objective: To develop an innovative, rapid, simple, cost effective, stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of ledipasvir (LP) and sofosbuvir (SB) in combination pill dosage form.


Methods: The method was developed using C8 column, 250 mm x 4.6 mm, 5mm using mobile section comprising of 0.1% (v/v) orthophosphoric acid buffer at pH 2.2 and acetonitrile in the ratio of 45:55 that was pumped through the column at a flow rate of 0.8 ml/min. Temperature was maintained at 30 °C, the effluents were monitored at 260 nm with the help of usage of PDA detector.


Results: The retention time of LP and SB were found to be 2.246 min and 3.502 min. The approach was found to be linear with the variety of 9-36 µg/ml and 40-240 μg/ml for LP and SB respectively, the assay of estimated compounds were found to be 99.65% and 99.73% w/v for LP and SB respectively.


Conclusion: The pressured samples changed into analyzed and this proposed a technique turned into determined to be particular and stability indicating as no interfering peaks of decay compound and excipients were observed. Hence, the approach was easy and economical that may be efficiently applied for simultaneous estimation of both LP and SB in bulk and combination tablet system.

Keywords: Ledipasvir, Sofosbuvir, Assay, ICH guidelines, Force degradation

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How to Cite
Reddy, B. A., M. I. Alam, N. Khanam, and P. R. Adhakrishnanand. “AN INNOVATIVE METHOD DEVELOPMENT AND FORCED DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR BY RP HPLC”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 11, no. 2, Dec. 2018, pp. 34-41, doi:10.22159/ijpps.2019v11i2.29347.
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