Volume : 13, Issue : 07, July – 2026

Title:

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AREA UNDER CURVE APPROACHES FOR TOLVAPTAN ESTIMATION IN BULK AND TABLET DOSAGE FORM

Authors :

Dr. Sowmya H G, Bhagyashree K C*, Dr. Naveen Kumar G S

Abstract :

Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Tolvaptan in bulk and Tablet dosage form. The drug shows maximum absorption (λmax) at 267nm in Acetonitrile solution and Area under Curve [AUC] in absorption spectra was measured between the wavelengths ranges 262 to 272nm which obeys Beer’s law in the concentration range of 3 – 18 µg/ml The linearity study was carried out and regression coefficient was found to be 0.998 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.66%,102.4% and 99.05%. The % relative standard deviation (%RSD) was found to be less than 2%. The LOD and LOQ were found to be 0.06µg/ml and 0.184µg/ml. According to ICH guidelines the method has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for routine Quantitation of Tolvaptan in bulk and pharmaceutical dosage form.
KEYWORDS: Tolvaptan ;Area Under curve;Validation; RP-HPLC; HPTLC, Anti-Diuretics.

Cite This Article:

Please cite this article in press Bhagyashree K C et al., Analytical Method Development And Validation Of Area Under Curve Approaches For Tolvaptan Estimation In Bulk And Tablet Dosage Form, Indo Am. J. P. Sci, 2026; 13(07).

REFERENCES:

1. Patil MR, Patil AS, Shirkhedkar AA. Novel and ecofriendly UV-Spectrophotometry methods for estimation of Tolvaptan using hydrotropic agent. International Journal of Pharmaceutical Chemistry and Analysis. 2019;6(4):115-9.
2. Kumudini Rahul Pawar, Sanjay K Bais. A Validated bioanalytical method for quantification of Tolvaptan by RPHPLC-UV. Journal of Population Therapeutics & Clinical Pharmacology.2022;04:985-994.
3. Patil MR, Patil AS, Shirkhedkar AA. Novel and ecofriendly UV-Spectrophotometry methods for estimation of Tolvaptan using hydrotropic agent. International Journal of Pharmaceutical Chemistry and Analysis. 2019;6(4):115-9.
4. 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.
5. Gandhi BM, Rao AL, Rao JV. A new stability-indicating and validated RP-HPLC method for the estimation of tolvaptan in bulk and pharmaceutical dosage forms. Asian Journal of Research in Chemistry. 2014 Jul 1;7(7):2.
6. Hashmi SA, Alegete P. QbD green analytical procedure for the quantification of tolvaptan by utilizing stability indicating UHPLC method. BMC chemistry. 2024 Jun 28;18(1):122.
7. Iram S, Pal S, Murtaja Ali MA, Ahamed M, Akther S. Analytic Method development And validation for the quantitative estimation of Tolvaptan in API form and its marketed pharmaceutical dosage form by RP-HPLC2024;13(2);30-38.
8. Sutar AS, Magdum CS. Application of response surface methodology in development and optimization of stability indicating RP-HPLC method for determination of tolvaptan in bulk and formulation. Journal of Pharmaceutical Research International. 2021 Oct 12;33(46A):137-48.
9. Bhavyasri K, Aishwarya B, Suchitra D, Sumakanth M. Spectrometric Bioanalytical Method Development and Validation of Tolvaptan in Spiked Human plasma Followed by Forced degradation Studies. Research Journal of Pharmacy and Technology. 2023 Dec 1;16(12):5996-6001.
10. Pawar KR, Kale PG, Nalawade MS, Chavan SS, Warude BJ, Kaldate DP. Methodological Advancements in Tolvaptan Analysis: HPLC-Based Stability Indication with LC-MS Validation. 2023;24(4):334-346.
11. Karadurmus L, Budak F, Cetinkaya A, Atici EB, Ozkan SA. Development of highly selective and sensitive molecularly imprinted polymer-based electrochemical sensors for tolvaptan assay in tablets and serum. Analytical Methods. 2023;15(40):5316-22.
12. Beaudoin JJ, Brock WJ, Watkins PB, Brouwer KL. Quantitative systems toxicology modeling predicts that reduced biliary efflux contributes to tolvaptan hepatotoxicity. Clinical Pharmacology & Therapeutics. 2021 Feb;109(2):433-42.
13. Hoshikawa K, Naito T, Saotome M, Maekawa Y, Kawakami J. Validated liquid chromatography coupled to tandem mass spectrometry method for simultaneous quantitation of tolvaptan and its five major metabolites in human plasma. Annals of Clinical Biochemistry. 2019 May;56(3):387-96.
14. 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.
15. Qazi SS, Khan GJ. Bioanalytical method development and Validation of tolvaptan. Indian J. Applied & Pure Bio. Vol. 2025;40(2):1155-61.
16. Liu H, Liu T, Liu M, Zheng X, Zhong W, Zhao Q, Jiang J, Hu P, Li Y. Clinical trial on the pharmacokinetics, pharmacodynamics and safety of tolvaptan in healthy Chinese males: an open-label, single and multiple dosage, parallel group study. Frontiers in Pharmacology. 2025 Nov 21;16:1713702.
17. ICH, Q2A text on validation of analytical procedures, 1994.
18. ICH, Q2B validation of analytical methodology, 1996.
19. ICH, Q2 (R1) validation of analytical procedures: text and methodology, 2005.