Author(s):
K. Bhavyasri, B. Aishwarya, D. Suchitra, M. Sumakanth
Email(s):
bhavya.khagga@gmail.com
DOI:
10.52711/0974-360X.2023.00973 
Address:
K. Bhavyasri 1*, B. Aishwarya2, D. Suchitra3, M. Sumakanth4
1,2Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad, 500027.
3Department of Pharmaceutical Analysis, Vision College of Pharmaceutical Sciences and Research, Boduppal, Hyderabad.
4Department of Pharmaceutical Chemistry, RBVRR Women’s College of Pharmacy, Barkatpura, Hyderabad, 500027.
*Corresponding Author
Published In:
Volume - 16,
Issue - 12,
Year - 2023
ABSTRACT:
Tolvaptan in bulk and formulation in spiking human plasma were estimated using a brand-new, straightforward, speedy, precise, and accurate bioanalytical method that was developed and validated using UV-visible spectrophotometer. The acetonitrile-based solvent chosen for the tolvaptan UV study was scanned over the UV spectrum from 200 to 400nm using a solution containing 10g/ml. At 267nm, Tolvaptan exhibits its greatest absorption. The accuracy investigations were conducted at three distinct levels, i.e., 80%, 100%, and 120%, and recovery was found to be in the range of 99.4%. The tolvaptan showed linearity over the range of 5-160g/mL with correlation coefficientnt (r2) of 0.999. The thresholds for detection and quantification were 0.471 and 1.435 g/ml, respectively. In accordance with ICH requirements, all the parameters were validated.
Cite this article:
K. Bhavyasri, B. Aishwarya, D. Suchitra, M. Sumakanth. Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies. Research Journal of Pharmacy and Technology.2023; 16(12):5996-1. doi: 10.52711/0974-360X.2023.00973
Cite(Electronic):
K. Bhavyasri, B. Aishwarya, D. Suchitra, M. Sumakanth. Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies. Research Journal of Pharmacy and Technology.2023; 16(12):5996-1. doi: 10.52711/0974-360X.2023.00973 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-12-74
REFERENCES:
1. ICH M10 Bioanalytical method validation and study sample analysis.
2. Kadam AS, Pimpodkar NV, Gaikwad PS, Chavan SD. Bioanalytical method validation. Asian Journal of Pharmaceutical Analysis. 2015; 5(4): 219-25 https://doi.org/10.5958/2231-5675.2015.00035.6
3. Saudagar RB, Thete PG. Bioanalytical method validation: a concise review. Asian Journal of Research in Pharmaceutical Science. 2018; 8(2): 107-14 https://doi.org/10.5958/2231-5659.2018.00019.x
4. Validation of analytical procedures text and methodology Q2 (R1) https://doi.org/10.1002/9781118971147.ch5
5. ICH Harmonized Tripartite Guideline, ICH Q2B (May 1997), Validation of analytical procedures: methodologyhttps://doi.org/10.1007/springerreference_83218
6. Patel AB. Analytical Method Validation: Collation between International Guidelines. Asian Journal of Research in Chemistry. 2017; 10(6): 857-66 https://doi.org/10.5958/0974-4150.2017.00143.2
7. O’Neil MJ, Heckelman PE, Koch CB, Roman KJ. An encyclopedia of chemicals, drugs and biologicals. Merck and Co, Whitehouse Station, NJ . 2006
8. Shoaf SE, Wang Z, Bricmont P, Mallikaarjun S. Pharmacokinetics, pharmacodynamics, and safety of tolvaptan, a nonpeptide AVP antagonist, during ascending single‐dose studies in healthy subjects. The Journal of Clinical Pharmacology. 2007; 47(12): 1498-507 https://doi.org/10.1111/j.1365-2125.2011.04114.x
9. Yi S, Jeon H, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetics and pharmacodynamics of oral tolvaptan administered in 15-to 60-mg single doses to healthy Korean men. Journal of Cardiovascular Pharmacology. 2012; 59(4): 315-22 https://doi.org/10.1097/fjc.0b013e318241e89c
10. Hauptman PJ, Zimmer C, Udelson J, Shoaf SE, Mallikaarjun S, Bramer SL, Orlandi C. Comparison of two doses and dosing regimens of tolvaptan in congestive heart failure. Journal of Cardiovascular Pharmacology. 2005; 46(5): 609-14 https://doi.org/10.1097/01.fjc.0000180899.24865.b6
11. Paul A, Lakshmi R. Tolvaptan in hyponatremia-a pharmacologic approach. Research Journal of Pharmacy and Technology. 2021; 14(6): 3455-60 https://doi.org/10.52711/0974-360x.2021.00601
12. Miyazaki T, Fujiki H, Yamamura Y, Nakamura S, Mori T. Tolvaptan, an Orally Active Vasopressin V2‐Receptor Antagonist—Pharmacology and Clinical Trials. Cardiovascular Drug Reviews. 2007; 25(1): 1-3https://doi.org/10.1111/j.1527-3466.2007.00001.x
13. Serradeil-Le Gal C, Wagnon J, Garcia C, Lacour C, Guiraudou P, et al,. Biochemical and pharmacological properties of SR 49059, a new, potent, nonpeptide antagonist of rat and human vasopressin V1a receptors. The Journal of Clinical Investigation. 1993 Jul 1;92(1):224-31https://doi.org/10.1172/jci116554
14. Yamamura Y, Nakamura S, Itoh S, Hirano T, Onogawa T, Yamashitha et al,. OPC-41061, a highly potent human vasopressin V2-receptor antagonist: pharmacological profile and aquaretic effect by single and multiple oral dosing in rats. Journal of Pharmacology and Experimental Therapeutics. 1998; 287(3): 860-7.
15. Shinde NG, Bangar BN, Deshmukh SM, Sulake SP, Sherekar DP. Pharmaceutical forced degradation studies with regulatory consideration. Asian Journal of Research in Pharmaceutical Science. 2013; 3(4): 178-88.
16. Sutar SV, Yeligar VC, Patil SS. A review: stability indicating forced degradation studies. Research Journal of Pharmacy and Technology. 2019; 12(2): 885-90 https://doi.org/10.5958/0974-360x.2019.00152.5
17. Sutar SV, Yeligar VC, Patil SS. Stability Indicating Forced Degradation Studies. Research Journal of Pharmacy and Technology. 2019; 12(1): 429-33 https://doi.org/10.5958/0974-360x.2019.00078.7
18. Sri KV, Sruthi S, Srinivas ID. UV Spectrophotometric Method for the Estimation of Tolvaptan in Bulk and Pharmaceutical Formulations. Asian Journal of Research in Chemistry. 2014; 7(9): 773-6.
19. Murugan S, Kumar NP, Kumar CK, Sundhar VS, Harika S, Anusha P. Method development and validation for dissolution method of Tolvaptan in bulk and tablet dosage form by UV spectrophotometry. Indian Journal of Pharmaceutical Science and Research. 2013; 3(1): 17-9.
20. Patil MR, Patil AS, Shirkhedkar AA. Novel and ecofriendly UV-Spectrophotometry methods for estimation of Tolvaptan using hydrotropic agent. International Journal of Pharmaceutical Chemistry. 2020;6:115-9 https://doi.org/10.18231/j.ijpca.2019.021
21. Sri KV, Sruthi S, Srinivas ID. UV Spectrophotometric Method for the Estimation of Tolvaptan in Bulk and Pharmaceutical Formulations. Asian Journal of Research in Chemistry. 2014; 7(9): 773-6
22. Vijaya Sri K, Sruthi S, Madhuri MA. Rapid RP-HPLC Method Development and Validation of Tolvaptan in Bulk and Pharmaceutical Dosage Form for an Internal Standard. Asian Journal of Pharmaceutical Analysis. 2017; 7(1): 36-40 https://doi.org/10.5958/2231-5675.2017.00007.2
23. Khaleela N, Rahamanb SK. Development and Validation of Novel Stability Indicating RP-HPLC Method for Quantification of Tolvaptan in Bulk and Pharmaceutical Dosage Form. by. 2020; 57(03): 62 https://doi.org/10.53879/id.57.03.11817
24. Gandhi BM, Rao AL, Rao JV. A New Stability-Indicating and Validated RPHPLC Method for the Estimation of Tolvaptan in Bulk and Pharmaceutical Dosage Forms. Asian J. Pharm. Anal. 2017; 12(2): 31-44.
25. Chakravarthy VK, Shankar DG. Development and validation of RP-HPLC method for estimation of Tolvaptan in bulk and its pharmaceutical formulation. Rasayan J. Chem. 2011; 4(1): 1165-71.
26. Prathyusha B, Shirisha B, Ramathilagam N, Priya J, Sekhar CK. Analytical method developmentand validation of Tolvaptan in bulk and tablet dosage form by RP-HPLC. WJ Pharmacy and Pharmaceutical Sciences. 2013;3:754-62.
27. Pei Q, Tan H, Liu L, Peng X, Li Z, Huang P, Luo M, Zuo X, Guo C, Yang G. Development and validation of an LC–MS/MS method for the determination of tolvaptan in human plasma and its application to a pharmacokinetic study. Journal of Chromatography B. 2013; 913: 84-9 https://doi.org/10.1016/j.jchromb.2012.11.027