Author(s):
Kiran Balasaheb Aher, Girija Balasaheb Bhavar, Madhav Ramdas Shelke, Sadikali Fakirmahmmad Sayyad
Email(s):
aherkiran22@gmail.com
DOI:
10.52711/0974-360X.2023.00632 
Address:
Kiran Balasaheb Aher1*, Girija Balasaheb Bhavar1*, Madhav Ramdas Shelke1, Sadikali Fakirmahmmad Sayyad2
1Shri Vile Parle Kelavani Mandal’s Institute of Pharmacy, Dhule, Maharashtra, India, 424001.
2Amrutvahini College of Pharmacy, Sangamner, Dist. Ahmednagar, Maharashtra, India, 422608.
*Corresponding Author
Published In:
Volume - 16,
Issue - 8,
Year - 2023
ABSTRACT:
For the quantitative measurement of sofosbuvir (SFR) in pharmaceutical formulation, high-performance thin-layer chromatographic (HPTLC) and environmentally friendly UV spectrophotometric approaches have been developed. HPTLC stationary phases were silica gel 60 F254-coated aluminium plates. Toluene, chloroform, and ethanol were mixed 4:4:1 v/v/v. This mobile phase produced tiny spots of SFR with Rf 0.30±0.01. SFR was densitometrically analysed at 267nm in absorbance mode. Peak area showed great linearity (r2 =0.998) in the dilution range of 100–800ng/spot. A solvent combination of methanol and water was utilised for the UV spectrophotometric technique. First, a stock solution of SFR was made in methanol, and then it was diluted further in water. Absorption maxima were observed at 261nm for the SFR standard solution. Beer-law Lambert's was followed by the SFR at an r2 value of 0.999 at 10-50ng/mL. Both methods met ICH standards for precision, LOD, LOQ, accuracy and specificity. Statistical study validated the methods as reliable and accurate for the estimation of the SFR. The established procedures can be applied to the regular analysis of SFR drugs and pharmaceuticals.
Cite this article:
Kiran Balasaheb Aher, Girija Balasaheb Bhavar, Madhav Ramdas Shelke, Sadikali Fakirmahmmad Sayyad. Environmentally Friendly Analytical Methods for Quantitative Measurement of Sofosbuvir in Pharmaceutical Formulations: Comparison of HPTLC and UV Spectrophotometric Approaches. Research Journal of Pharmacy and Technology. 2023; 16(8):3830-6. doi: 10.52711/0974-360X.2023.00632
Cite(Electronic):
Kiran Balasaheb Aher, Girija Balasaheb Bhavar, Madhav Ramdas Shelke, Sadikali Fakirmahmmad Sayyad. Environmentally Friendly Analytical Methods for Quantitative Measurement of Sofosbuvir in Pharmaceutical Formulations: Comparison of HPTLC and UV Spectrophotometric Approaches. Research Journal of Pharmacy and Technology. 2023; 16(8):3830-6. doi: 10.52711/0974-360X.2023.00632 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-8-52
REFERENCES:
1. Saxena A, Sharma S, Shukla A. Development and validation of a UV spectrophotometric method for the estimation of sofosbuvir in bulk and tablet dosage forms. Journal of Pharmacy and Bioallied Sciences. 2016;8(2):152-155. doi:10.4103/0975-7406.171700
2. Bhatia M, Ahuja S, Kumar N, Sharma D. Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Estimation of Sofosbuvir in Bulk and Pharmaceutical Dosage Form. Journal of Chromatographic Science. 2016;54(10):1807-1814. doi:10.1093/chromsci/bmw132
3. Yallappa, S., Anand, R., & Rao, R. N. (2016). Development and validation of a stability indicating RP-UPLC method for the determination of sofosbuvir in bulk and pharmaceutical dosage forms. Journal of Chromatographic Science. 54(10), 1793-1800.
4. Shinde VC, Aher KB, Bhavar GB, Kakad SJ, Chaudhar SR. Development and validation of UV spectrophotometric method and high-performance thin layer chromatographic (HPTLC) method for estimation of teneligliptin hydrobromide in pharmaceutical preparation. Der Pharmacia Lettre. 2016, 8(8): 291-301.
5. Kalyankar, T. M., Pore, Y. V., & Puranik, V. G. (2017). Stability indicating HPLC method for the determination of Sofosbuvir in bulk and pharmaceutical dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 9(1), 128-134.
6. Patel C, Patel D, Patel K. Simultaneous Estimation of Sofosbuvir and Ledipasvir by UV Spectrophotometry in Pharmaceutical Dosage Form. Journal of Analytical Methods in Chemistry. 2017; 1-7. doi:10.1155/2017/4138372
7. Hassouna MR, and Mohamed MA. UV-Spectrophotometric and Stability Indicating RP-HPLC Mohamed AE, Ramadan A, Marzouk A, Osama HA. Validated Ultraviolet-Spectrometric Method for Determination of Sofosbuvir in Tablets Formulation. J Applied Pharma Sci. 2017; 7(02): 114-119. DOI: 10.7324/JAPS.2017.70214
8. Methods for the Determination of the Hepatitis C Virus Inhibitor Sofosbuvir in Tablet Dosage Form, Anal Chem Letters. 2018; 8(2): 217-22. DOI: 10.1080/22297928.2017.1410441
9. Zaman B, Hassan W. Development of Stability Indicating HPLC–UV Method for determination of daclatasvir and characterization of forced degradation products. Chromatographia. 2018; 81: 785–797.1 DOI:10.1007/s10337-018-3503-7
10. Ahmed A, Mahtab T, Saleem S, Akula S, Khan MD. Validation of RP-HPLC Method for Determination of Sofosbuvir in Bulk and Pharmaceutical Dosage Forms. Int J Pharmal Sci Nanotech. 2020; 31;13(2):4826-30.
11. Rathod, R. U., Navyasree, K. S., & Bhat, K. (2018). Quantification of Sofosbuvir in Human Plasma: RP-HPLC Method Development and Validation. Pharmaceutical Chemistry Journal. 52(7), 663-673. https://doi.org/10.1007/s11094-018-1878-2
12. Ghante MR, Sawant SD, Shinde A, Bhusari VK. Development and validation of stability indicating HPTLC method for the estimation of sofosbuvir. Int J Pharma Sci Res. 2021; 12(5): 2656-2661. DOI: 10.13040/IJPSR.0975-8232.12(5).2656-61
13. Pekamwar SS, Kalyankar TM, Shelke M. Simultaneous estimation of levocetrizine dihydrochloride and ambroxol hydrochloride in syrup dosage form by using UV spectrophotometric method. Int. Res J Pharm. 2015; 6(8):562-566 http://dx.doi.org/ 10.7897/2230-8407.068111
14. Mostafa NM, Hegazy MA, Abdelaziz LM, Khedr A, Abouzid KA. Determination of sofosbuvir in the presence of its oxidative degradate and its tablets: An analytical study. J Liq Chromatogr Relat Technol. 2016; 39(1): 38-47. doi: 10.1080/10826076.2015.1056251
15. Liu H, Xie Y, Xue H, Huang Q, Ding L, Shen C, Xu H, Ding G, Chen L. Simultaneous determination of sofosbuvir and its metabolite GS-331007 in human plasma by UPLC-MS/MS and its application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2016; 1022:112-118. doi: 10.1016/j.jchromb.2016.06.016
16. Abdelwahab NS, Hegazy MA, Farid DF, Abouzid KA. A validated stability-indicating HPLC-DAD method for determination of sofosbuvir in its dosage form and its stress degradation products. J Chromatogr Sci. 2017; 55(4): 417-426. doi: 10.1093/chromsci/bmw222
17. Mirza T, Ahmad R, Khan S. Simultaneous determination of Sofosbuvir and Ledipasvir by validated RP-HPLC method: application to tablets dosage form. J Liq Chromatogr Relat Technol. 2018; 41(3):165-172.
18. Pise HN, Jadhav NR, Bobade AS, Sangshetti JN. Stability Indicating RP-HPLC Method for Determination of Sofosbuvir in Bulk and Pharmaceutical Dosage Form. Journal of Chromatographic Science. 2018; 56(7): 647-653. doi:10.1093/chromsci/bmy035
19. S. Hemchand, R. Ravi Chandra Babu, Mukthinuthalapati Mathrusri Annapurna. New stability indicating RP-UFLC method for the simultaneous determination of Velpatasvir and Sofosbuvir in tablets. Research J. Pharm. and Tech. 2018; 11(12): 5637-5642. doi: 10.5958/0974-360X.2018.01022.
20. Tarek M, Al-Talla ZA, Alqarni MH, Al-Talla ZH. Simultaneous determination of sofosbuvir and ledipasvir in human plasma by UPLC-MS/MS: Application to a pharmacokinetic study. Biomed Chromatogr. 2018; 32(6): e4206. doi: 10.1002/bmc.4206
21. P. Venkateswara Rao, A. Lakshmana Rao, S.V.U.M. Prasad. Validated Stability Indicating RP-HPLC method for estimation of antiviral class of drugs Sofosbuvir and Velpatasvir in combination and its comparison with reported methods. Research J. Pharm. and Tech. 2018; 11(12): 5425-5430. doi: 10.5958/0974-360X.2018.00990.3
22. B. Balaswami, P. Venkata Ramana, B. Subba Rao, P. Sanjeeva. A New Simple Stability-Indicating RP-HPLC- PDA Method for Simultaneous Estimation of Triplicate Mixture of Sofosbuvir, Velpatasvir and Voxilaprevir in Tablet Dosage Form. Research J. Pharm. and Tech. 2018; 11(9): 4147-4156. doi: 10.5958/0974-360X.2018.00762.X
23. Singh K, Bhatt S, Prasad R. HPLC method for estimation of drug release of sofosbuvir in Pharmaceutical formulation. Int J Pharma Sci Res. 2019; 10(1): 367-372. DOI: 10.13040/IJPSR.0975-8232.10(1).367-72.
24. Ambasana MA, Patel CN, Patel MM, Patel BA. Development and validation of spectrophotometric and HPLC methods for simultaneous estimation of Sofosbuvir and Velpatasvir in tablet dosage form. Journal of Taibah University Medical Sciences. 2019; 14(5): 428-437. doi:10.1016/j.jtumed.2019.06.001
25. Patil SA, Shinde VN, Shirkhedkar AA, Surana SJ. Development and validation of RP-HPLC method for the simultaneous determination of Sofosbuvir and Daclatasvir in bulk and tablet dosage form. J Drug Deliv Ther. 2019;9(3):154-159.
26. Nakka Raju, P. Raveendra Reddy, P. Janaki Pathi, N. Appala Raju. Visible Extractive Spectrophotometric Estimation of Sofosbuvir in Bulk and in Pharmaceutical Formulations. Research J. Pharm. and Tech. 2019; 12(4):1517-1520. doi: 10.5958/0974-360X.2019.00251.8
27. Manal El-Hamamsy, Gouda K Helal, Soheir AbolAzm, Mohamed El Kassas, Heba A Abdel-Aziz, Sara Shaheen. Clinical Evaluation of Some Sofosbuvir-Based Regimens for the Treatment of Hepatitis C in Private healthcare sector in Egypt. Research J. Pharm. and Tech. 2020; 13(12):5903-5908. doi: 10.5958/0974-360X.2020.01030.6
28. Maya S. Eissa, Ahmed S. Fayed, Maha A. Hegazy, Ebram B. Kamel. Spectrophotometric analysis for simultaneous determination of the new Antiviral drug combination: Daclatasvir/Sofosbuvir in their pure form and Pharmaceutical Preparation. Research J. Pharm. and Tech. 2020; 13(12):5939-5946. doi: 10.5958/0974-360X.2020.01037.9
29. Tej Kumar Kokkirala, Duvvuri Suryakala. Stability indicating RP-HPLC Method development and Validation for the Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Bulk and Pharmaceutical dosage form. Research J. Pharm. and Tech. 2020; 13(11):5063-5071. doi: 10.5958/0974-360X.2020.00887.2
30. El-Yazbi FA, Mousa SA, Hamdy DA, El-Sherbiny DT, Attia EZ. Development and validation of a simple, rapid and highly sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantitation of sofosbuvir in rat plasma: Application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2020; 1138: 121973. doi: 10.1016/j.jchromb.2020.121973
31. Kamble SS, Jadhav AB, Saudagar RB. Analytical Method Development and Validation of Sofosbuvir and Velpatasvir in Bulk and Pharmaceutical Dosage Form by RP-HPLC. J Chromatogr Sci. 2020;58(10):923-929. doi:10.1093/chromsci/bmaa040.
32. Ahmed SM, Ibrahim FA, Elzanfaly ES, Omar MA. A stability-indicating RP-UPLC method for determination of Sofosbuvir and Velpatasvir in binary mixtures and tablets dosage form. J Pharm Anal. 2020;10(5):440-450.
33. Hegazy MA, Gouda AA, Abdallah RM, Mohamed NA, Emam AM. RP-HPLC method for the simultaneous determination of Sofosbuvir, Daclatasvir, and Ribavirin in pharmaceutical formulations. J Liq Chromatogr Relat Technol. 2021;44(7-8):296-304.
34. Singh P, Goyal VK, Singh SK. A novel and simple UPLC method for simultaneous determination of sofosbuvir, ledipasvir, and velpatasvir in binary and ternary mixtures. J Liq Chromatogr Relat Technol. 2021; 44(4): 221-232.
35. Ganji S, Dhulipala S, Nemala, AR. Development and validation of RP HPLC method for the estimation of Sofosbuvir and related impurity in bulk and pharmaceutical dosage form. Futur J Pharm Sci. 2021; 7: 154. DOI: 10.1186/s43094-021-00285-5
36. Bhairav BA, Chavan MJ. Method Development and Validation to Estimate Sofosbuvir in Marketed preparation by UV-Spectroscopy and HPLC along with force Degradation Study. Res J Pharma Tech. 2021; 14(8): 4165-72. doi: 10.52711/0974-360X.2021.00721.
37. ICH harmonized tripartite guideline, validation of analytical procedures: text and methodology Q2(R1). 2005; 1-13.