Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease

Mitalben Parmar; Dimal Shah; Usmangani Chhalotiya

doi:10.12991/jrespharm.1631220

Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease

Abstract

Novel drug Tegoprazan has been introduced for the treatment of gastro-esophageal reflux disease. Accurate and precise thin layer chromatographic method has been developed and validated for estimation of tegoprazan. Silica gel G 60 F254 (20cm×20cm) coated aluminium backed plates were used as stationary phase and mixture of Toluene: Methanol (7.5: 2.5 v/v) was used as mobile phase. The compact band (Rf values 0.53 ± 0.1) was obtained for Tegoprazan. The method was found to be linear in the concentration range of 100 -700 ng/band with a linear regression equation showing linear relationship with R2 =0.9944. The method was validated as per ICH Q2 (R2) guidelines Forced degradation studies were carried out to assess molecule’s intrinsic stability, using acid and base hydrolysis, oxidative stress and photolytic degradation. Forced degradation study revealed that Tegoprazan was highly susceptible to acid hydrolysis. Greenness assessment for develop method was conducted using AGREE and White analytical chemistry. The evaluation confirmed environmentally friendly nature of developed method.

Keywords

References

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Details

Primary Language

English

Subjects

Pharmaceutical Analytical Chemistry

Journal Section

Research Article

Authors

Mitalben Parmar
0000-0003-3473-0573
India

Dimal Shah ^*
0000-0002-6358-3739
India

Usmangani Chhalotiya
0000-0003-1183-2761
India

Publication Date

January 11, 2026

Submission Date

February 1, 2025

Acceptance Date

May 13, 2025

Published in Issue

Year 2026 Volume: 30 Number: 1

DOI

https://doi.org/10.12991/jrespharm.1631220

IZ

https://izlik.org/JA62ZN23HM

Cite

RIS / Bibtex

APA

Parmar, M., Shah, D., & Chhalotiya, U. (2026). Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease. Journal of Research in Pharmacy, 30(1), 237-245. https://doi.org/10.12991/jrespharm.1631220

AMA

1.Parmar M, Shah D, Chhalotiya U. Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease. J. Res. Pharm. 2026;30(1):237-245. doi:10.12991/jrespharm.1631220

Chicago

Parmar, Mitalben, Dimal Shah, and Usmangani Chhalotiya. 2026. “Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan Used in the Treatment of Gastroesophageal Reflux Disease”. Journal of Research in Pharmacy 30 (1): 237-45. https://doi.org/10.12991/jrespharm.1631220.

EndNote

Parmar M, Shah D, Chhalotiya U (January 1, 2026) Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease. Journal of Research in Pharmacy 30 1 237–245.

IEEE

[1]M. Parmar, D. Shah, and U. Chhalotiya, “Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease”, J. Res. Pharm., vol. 30, no. 1, pp. 237–245, Jan. 2026, doi: 10.12991/jrespharm.1631220.

ISNAD

Parmar, Mitalben - Shah, Dimal - Chhalotiya, Usmangani. “Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan Used in the Treatment of Gastroesophageal Reflux Disease”. Journal of Research in Pharmacy 30/1 (January 1, 2026): 237-245. https://doi.org/10.12991/jrespharm.1631220.

JAMA

1.Parmar M, Shah D, Chhalotiya U. Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease. J. Res. Pharm. 2026;30:237–245.

MLA

Parmar, Mitalben, et al. “Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan Used in the Treatment of Gastroesophageal Reflux Disease”. Journal of Research in Pharmacy, vol. 30, no. 1, Jan. 2026, pp. 237-45, doi:10.12991/jrespharm.1631220.

Vancouver

1.Mitalben Parmar, Dimal Shah, Usmangani Chhalotiya. Development of Stability Indicating Densitometric Method for Estimation of Tegoprazan used in the Treatment of Gastroesophageal Reflux Disease. J. Res. Pharm. 2026 Jan. 1;30(1):237-45. doi:10.12991/jrespharm.1631220