DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF LEDIPASVIR AND SOFOSBUVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM
Abstract
The day by day new combinations drugs are being introduced in market. Then the multiple therapeutic agents which acts at different sites are used in the management of various diseases and disorders are done. Thus it is necessary to develop methods for analysis with the help of number of analytical techniques which are available for the estimation of the drugs in combination. The analyst were determine the Specific, accurate, simple, selective and stability-indicating RP-HPLC method is developed and validated for simultaneous determination of sofosbuvir and ledipasvir in tablet dosage form. RP-HPLC method was performed on the systronics isocratic HPLC System equipped with SP930 D HPLC pump and dual wavelength UV-VIS detector and C18 column (250 mm × 4.6 mm, 5μm), using the mobile phase (Methanol: Water 83:17 v/v) pH 3.0 with 0.05% acidic acid at a flow rate of 1.0 ml/min, injection volume 20μl and UV detection at 245 nm. This method is validated according to BP, USP and ICH requirements for new methods, which include accuracy, precision, robustness, ruggedness, lod, loq, linearity and range. Linear relationships were obtained in the ranges of 10-50μg/ml and 40-200μg/ml with correlation coefficients of 0.9991 and 0.9994 at Rt value of 7.45 min and 3.50 min for sofosbuvir and ledipasvir respectively. The forced degradation studies as acidity, alkalinity, oxidation and hydrolytic degradation were performed according to ICH guidelines.
Keywords:
Sofosbuvir and Ledipasvir, HPLC, Development, Forced degradation, Validation.DOI
https://doi.org/10.25004/IJPSDR.2017.090602References
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14. Madhavi S, Prameela Rani A. Bioanalytical Method Development and Validation for the Determination of Sofosbuvir from Human Plasma. International Journal of Pharmacy and Pharmaceutical Sciences. 2017; 9(3): 35-41.
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16. Rai SY, Prajapati Y, Patni P. Development and Validation of RP-HPLC and UV Spectroscopy Methods for Simultaneous Estimation of Sofosbuvir and Ledipasvir in Their Combined Tablet Dosage Form. Pharma Science Monitor An International Journal of Pharmaceutical Sciences. 2017; 8(2): 369-388.
17. Kothapalli KK, Saisri M, Priyanka M, Subhashini M, Manikanta M. A New Analytical Method Development and Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir Using RP-HPLC. Intercontinental Journal of Pharmaceutical Investigations and Research. 2017; 4(1): 142-165.
18. Hassouna MEM, 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 & Criminal Inves. 2017; 1(3): 555562.
19. Yogendrachari K, Madhu M, Kumar EG, Kumari MV, Naik MC. Analytical Method Development and Validation for Simulta-Neous Determination of Ledipasvir and Sofosbuvir in Tablet Dosage Form By RP-HPLC. Journal of Global Trends in Pharmaceutical Sciences. 2016; 7(3): 3401- 3407.
20. 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. December 2016; 79 (23): 1605–1613.
21. Abdulkareem A, El-Tohamy MF. Validated Capillary Zone Electrophoresis Approach For Simultaneous Separation and Determination of Hepatitis C Sofosbuvir and Ledipasvir In Tablet Dosage Form. World Journal of Pharmaceutical Research. 2017; 6(5):129-147.
22. Rezk MR, Basalious EB, Amin ME. Novel and Sensitive UPLC–MS/MS Method for Quantification of Sofosbuvir in Human Plasma: Application to a Bioequivalence Study. Biomedical Chromatography. 2016; 30(9):1354-1362.
23. Shi X, Zhu D, Lou J, Zhu B, Hu A-R, Gan D. Evaluation of A Rapid Method For The Simultaneous Quantification of Ribavirin, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC–MS/MS. Journal of Chromatography. 2015; 10(02): 353-357.
24. Pan C, Chen Y, Chen W, Zhou G, Jin L, Zheng Y, Lin W, Pan Z. Simultaneous Determination of Ledipasvir, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC–MS/MS and Its Application To A Pharmacokinetic Study. Journal of Chromatography B. 2016; 1008: 255-259.
25. Suryawanshi R, Shinde N, Todkar G. Development and Validation of Simple UV Spectrophotometric Method for the Determination of Ledipasvir in Bulk Form and Stress Degradation Studies. Inventi Rapid: Pharm Analysis & Quality Assurance. 2016; (3): 1-5.
2. Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C. Gilead Sciences. 2014.
3. Jeffery GH, Bassett J, Mandham J, Denny RC. Vogel’s Text Book of Quantitative Chemical Analysis. 5th Ed. Longman Scientific and Technical Publication, UK, 1994, pp. 3-4.
4. Watson DG. Pharmaceutical Analysis. 1st ed. Churchill Livingstone, Edinburgh, 1999, pp. 1-11.
5. Ewing GW. Analytical Instrumentation Handbook. 2nd Ed. Marcel Dekker Inc. New York, 1997, pp. 1-2.
6. Kasture AV, Wadodkar SG, Mahadik KR. A Textbook of Pharmaceutical Analysis. Volume -II. 17th Ed. Nirali Prakashan, Pune, 2007, pp. 148-149.
7. Chatwal GR, Anand SK. Instrumental Methods of Chemical Analysis. 5th Ed. Himalaya Publishing House, New Delhi, 2004, pp. 1.6-1.8.
8. United States Pharmacopeia, Validation of Compedial Methods. Asian ed. Pharmacopeial Convention, Inc., US. Rockville Md, 2009, pp. 734-736.
9. Indian Pharmacopoeia. Govt. of India. Ministry of Health and Family Welfare, Published By the Indian Pharmacopoeia Commission, Ghaziabad, 2007, pp. 247, 747-749.
10. Jeyabaskaran M, Rambabu C, Rajinikanth V. A New RP-HPLC Method Development and Validation of Sofosbuvir in Bulk and Pharmaceutical Dosage Forms. Journal of Pharmacreations. 2014; 1(4):125-133.
11. Vejendla R, Subramanyam CVS, Veerabhadram G. Estimation and Validation of Sofosbuvir in Bulk and Tablet Dosage Form By RP-HPLC. International Journal of Pharmacy. 2016; 6(2): 121-127.
12. Guguloth R, Madhukar, Kanna N, Ravinder A, Sravanthi K. Analytical Method Development and Validation of Sofosbuvir Tablets by RP-HPLC. Journal of Pharma Research. 2016; 5(7): 161-163.
13. Vikas PM, Satyanarayana T, Vinod Kumar D, Mounika E, Sri Latha M, Anusha R, Sathish Y. Development and Validation of New RP-HPLC Method for the Determination of Sofosbuvir in Pure Form. World Journal of Pharmacy and Pharmaceutical Science. 2016; 5(5): 775-781.
14. Madhavi S, Prameela Rani A. Bioanalytical Method Development and Validation for the Determination of Sofosbuvir from Human Plasma. International Journal of Pharmacy and Pharmaceutical Sciences. 2017; 9(3): 35-41.
15. Devilal J, Durgaprasad B, Pal N, Srinivasa Rao A. 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. 2016; 5(8): 1312-1321.
16. Rai SY, Prajapati Y, Patni P. Development and Validation of RP-HPLC and UV Spectroscopy Methods for Simultaneous Estimation of Sofosbuvir and Ledipasvir in Their Combined Tablet Dosage Form. Pharma Science Monitor An International Journal of Pharmaceutical Sciences. 2017; 8(2): 369-388.
17. Kothapalli KK, Saisri M, Priyanka M, Subhashini M, Manikanta M. A New Analytical Method Development and Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir Using RP-HPLC. Intercontinental Journal of Pharmaceutical Investigations and Research. 2017; 4(1): 142-165.
18. Hassouna MEM, 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 & Criminal Inves. 2017; 1(3): 555562.
19. Yogendrachari K, Madhu M, Kumar EG, Kumari MV, Naik MC. Analytical Method Development and Validation for Simulta-Neous Determination of Ledipasvir and Sofosbuvir in Tablet Dosage Form By RP-HPLC. Journal of Global Trends in Pharmaceutical Sciences. 2016; 7(3): 3401- 3407.
20. 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. December 2016; 79 (23): 1605–1613.
21. Abdulkareem A, El-Tohamy MF. Validated Capillary Zone Electrophoresis Approach For Simultaneous Separation and Determination of Hepatitis C Sofosbuvir and Ledipasvir In Tablet Dosage Form. World Journal of Pharmaceutical Research. 2017; 6(5):129-147.
22. Rezk MR, Basalious EB, Amin ME. Novel and Sensitive UPLC–MS/MS Method for Quantification of Sofosbuvir in Human Plasma: Application to a Bioequivalence Study. Biomedical Chromatography. 2016; 30(9):1354-1362.
23. Shi X, Zhu D, Lou J, Zhu B, Hu A-R, Gan D. Evaluation of A Rapid Method For The Simultaneous Quantification of Ribavirin, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC–MS/MS. Journal of Chromatography. 2015; 10(02): 353-357.
24. Pan C, Chen Y, Chen W, Zhou G, Jin L, Zheng Y, Lin W, Pan Z. Simultaneous Determination of Ledipasvir, Sofosbuvir and Its Metabolite in Rat Plasma By UPLC–MS/MS and Its Application To A Pharmacokinetic Study. Journal of Chromatography B. 2016; 1008: 255-259.
25. Suryawanshi R, Shinde N, Todkar G. Development and Validation of Simple UV Spectrophotometric Method for the Determination of Ledipasvir in Bulk Form and Stress Degradation Studies. Inventi Rapid: Pharm Analysis & Quality Assurance. 2016; (3): 1-5.
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01-11-2017
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“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, vol. 9, no. 6, Nov. 2017, pp. 291-8, https://doi.org/10.25004/IJPSDR.2017.090602.
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How to Cite
“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, vol. 9, no. 6, Nov. 2017, pp. 291-8, https://doi.org/10.25004/IJPSDR.2017.090602.
