Analytical method development & validation for the simultaneous estimation of ledipasvir and sofosbuvir in bulk and it’s dosage form by rp-hplc
Keywords:
Sofosbuvir and LedipasvirAbstract
A simple reverse phase liquid Chromatographic method has been developed and subsequently validated for simultaneous determination of Sofosbuvir and Ledipasvir in combination. The separation was carried out using a mobile phase of phosphate buffer (0.05M) pH 7: MeOH (30:70%v/v) (pH was adjusted with orthophosphoric acid) and using methanol as diluent. The column used was Xterra C18 (150 x 4.6 mm i.d., 5?m) with flow rate of 1 ml/min using UV detection at 270 nm. The retention times of Sofosbuvir and Ledipasvir were found to be 2.399 and 3.907min respectively. Results of analysis were validated statistically and by recovery studies. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Sofosbuvir and Ledipasvir bulk drug and in its pharmaceutical dosage form.
Downloads
References
G.R.Chatwal, S.K.Anand, “Text book of Instrumental Methods of Chemical Analysis”, Himalaya Publishing House; 5th Edn, 2002; 2.566-2.570.
G.W.Ewing, “Text book of Instrumental Methods of Chemical Analysis”, Mc Graw- Hill Book Company; 5th Edn; 375-385.
B.K. Sharma, “T e x t b o o k of Instrumental M e t h o d s of Chemical Anal ysis ” , GOEL publishing house, Meerut; 23rd Edn; 288-289.
G.Vidyasagar, “Textbook of Instrumental Methods of Drug Analysis”, Pharmamed Press, 2009; 106-120.
H. H Willard, L.L Merritt, J . A Dean, and F. A Settle, “ Textbook of Instrumental Methods of Analysis”, CBS publishers and distributors, New Delhi; 7th Edn, 1986; 592-596.
H.H.Tackett, J.A.Cripe, G.Dyson, Positive displacement reciprocating pump fundamentals-power and direct acting types, Proceedings of the twenty-fourth international pump user’s symposium, 2008; 45-58.
D.A.Skoog, F.J.Holler, S.R.Crouch, “Textbook of Instrumental Analysis, Brooks/Cole”, Cengage Learning India Private Limited, 2007; 900-906.
R. E. Schirmer, “ Textbook of Modern Methods of Pharmaceuticals”, CRC press, 2nd Edn; 242-244.
LR.Snyder, JJ Kirkland, LG.Joseph, “Practical HPLC Method Development”, Wiley Inter Science, New York; 2nd Edn, 1997; 1-56.
Ranjith singh, “ J Pharm. Educ”. Res., 4; 2013; 26-33.
ICH: Q2B, “Analytical Validation”– Methodology, 1996.
Raghu Ram Jampala, V. Kiran Kumar, Appala Raju Nemala, Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine, and Sofosbuvir in Fixed Dosage Form. “Pharmaceutical Methods”, Jan-Jun 2014; 5(1).
V.V. Raveendra Babu, Pankaj K. Sharma and I. Singhvi, A New Gradient Liquid Chromatographic Method for Simultaneous Estimation of Tenofovir Disoproxil Fumarate, Cobicistat, Emtricitabine and Ledipasvir in Bulk Drug and Tablet Dosage Form. “Asian J. Chem”., 2014; 26(18): 6233-6237.
Urooj Fatima, T. Mamatha and Rajesh Goud Gajula, A novel RP-HPLC method development and validation of Sofosbuvir in bulk drug and tablet dosage form. “Der Pharmacia Sinica”, 2014; 5(5): 99-105.
Chandni Saha, Md.Nazeeruddin Ahmed, Development And Validation Of A Simple Uv Spectrophotometric Method For The Determination Of Sofosbuvir In Its Bulk Form. “Indo Americal Journal of Pharmaceutical Research”, 2014; 4(12): 5792-5796
Padigela Swetha, V. V. S. Rajendra Prasad, M. Bhagavan Raju, N. Suresh Kumar, Estimation Of Ledipasvir In Tablet Dosage Forms By Rp-Hplc. “Indo Americal Journal of Pharmaceutical Research”, 2013; 3(6): 4697-4705.
Swati S.Pardhi, Kiran B.Aher, Girija B.Bhavar, S.R.Chaudhari, Development And Validation Of Uv Spectrophotometric Method For The Estimation Of Ledipasvir In Bulk And Pharmaceutical Formulations. “International Journal of Pharma Sciences and Research”, 2012; 6(01). RowthulaPrasanna Surya Bhavani, R. P. S. B., an
M. M. M.Sandhya Maduri. “stability indicating method development and validation for the simultaneous estimation of ledipasvir and sofosbuvir in bulk drug by using rp-hplc”. World Journal of Current Medical and Pharmaceutical Research, Nov. 2020, pp. 307-18, doi:10.37022/wjcmpr.vi.159.
K, V. G., T. K, and S. P. P. “A New Stability Indicating Analytical Method Development And Validation for The Quantitative Determination of Emitricitabine And Lamivudine By RP-HPLC”. World Journal of Current Medical and Pharmaceutical Research, Vol. 2, no. 2, May 2020, pp. 184-90, doi:10.37022/WJCMPR.2020.2219
www.wikipedia.com
Published
How to Cite
Issue
Section

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.