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Author(s): Nansi Hadvani*11, Dr. Dinesh Dangar22, Dr. Amitkumar Vyas33

Email(s): 1nansihadvani@gmail.com

Address:

    1. Pharmaceutical Quality Assurance, Dr. Subhash University, Dr. Subhash Road, Joshipura, Junagadh, Gujarat 362001 2. School of Pharmacy, Dr. Subhash University, Dr. Subhash Road, Joshipura, Junagadh, Gujarat 362001 3. Pharmaceutical Quality Assurance, B.K. Mody Govt. Pharmacy College, Polytechnic Campus, Bhavnagar Rd, Near Aji Dam Road, GIDC, Rajkot, Gujarat 360003

Published In:   Volume - 4,      Issue - 7,     Year - 2025

DOI: https://doi.org/10.71431/IJRPAS.2025.4704  

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ABSTRACT:
Fixed dose combination of Rosuvastatin and Teneligliptin Hydrobromide Hydrate is proposed to reduce the risk of heart disease and stroke in patient with type 2 Diabetes mellitus and Dyslipidemia disease. The two-drug combination yield significant reduction in plasma glucose and low-density lipoprotein level in patient according to the data from clinical trial in Synokem Pharmaceutical LTD. Delhi, India. A simple, precise and accurate HPTLC method has been developed and validated for quantitative determination of Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate from its tablet formulation. The method involved separation of components on a pre- coated TLC silica gel 60 F254 plate using a mixture of Toluene: Methanol: Ethyl acetate: Glacial acetic acid: Triethanolamine (5: 3: 2: 0.1: 0.1 v/v/v/v/v) as a mobile phase. Detection of spots was carried out at 246 nm for Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate both. The mean Retardation factor for Rosuvastatin Calcium & Teneligliptin Hydrobromide Hydrate found to be 0.86 + 0.011 and 0.25 + 0.003, respectively. The Linear regression data for the calibration plots showed good linear relationship with R2 value 0.996 & 0.999 in the concentration range of 1-5 μg/band and 2-10 μg/band for Rosuvastatin Calcium & Teneligliptin Hydrobromide Hydrate respectively. The developed method was then validated as per ICH Q2 R2 guidelines.

Cite this article:
Nansi Hadvani, Dr. Dinesh Dangar, Dr. Amitkumar Vyas. High Performance Thin Layer Chromatography method for estimation of Rosuvastatin Calcium and Teneligliptin Hydrobromide Hydrate from its tablet dosage form. IJRPAS, July 2025; 4 (7): 38-47.DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2025.4704


1.      Quirk J, Thornton M, Kirkpatrick P. Rosuvastatin calcium. Nature Reviews Drug Discovery. 2003 Oct 1;2(10):769-70.

2.      Sharma SK, Panneerselvam A, Singh KP, Parmar G, Gadge P, Swami OC. Teneligliptin in management of type 2 diabetes mellitus. Diabetes, metabolic syndrome and obesity: targets and therapy. 2016 Aug 16:251-60.

3.      Gupta A, Mishra P, Shah K. Simple UV spectrophotometric determination of rosuvastatin calcium in pure form and in pharmaceutical formulations. Journal of Chemistry. 2009;6(1):89-92.

4.      Rajkondwar VV, Maini P, Vishwakarma M. Characterization and method development for estimation and validation of Rosuvastatin Calcium by UV–visible spectrophotometry. Int J Theoret Appl Sci. 2009;1(1).

5.       Maruthi R, Chandan RS, Barath M, Datta GN, D'silva M, Kumari KM, Ahmad F, Geetha R. Analytical method development and validation of teneligliptin by UV spectroscopy. Research Journal of Pharmacy and Technology. 2021;14(1):75-8.

6.      Yadav N, Goyal A. Method development and validation of Teneligliptin in pharmaceutical dosage form by UV spectrophotometric methods. International Journal of Pharmaceutical Chemistry and Analysis. 2017;4(3):54-8.

7.      Kumar TG, Vidyadhara S, Narkhede NA, Silpa YS, Lakshmi MR. Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy. Journal of Analytical Science and Technology. 2016 Dec 2;7(1):27.

8.      Trivedi HK, Patel MC. Development and validation of a stability-indicating RP-UPLC method for determination of rosuvastatin and related substances in pharmaceutical dosage form. Scientia pharmaceutica. 2012 Mar 26;80(2):393.

9.      Patel R, Shah J, Patel M. Analytical Quality by Design Based HPLC for Quantitative Analysis of Teneligliptin and Rosuvastatin Calcium Tablets in the Presence of Force Degradation Products. Separation Science Plus. 2025 Jan;8(1):e202400229.

10.  Vyas AJ, Vadile HM, Godhaniya JP, Jadav CD, Patel AI, Patel AB, Dudhrejiya AV, Shah SR, Chotaliya UJ, Sheth DB. RP-HPLC Method Development and Validation for Simultaneous Estimation of Rosuvastatin calcium and Teneligliptin hydrobromide hydrate in Synthetic Mixture. Research Journal of Pharmacy and Technology. 2024 Sep 1;17(9):4325-8.

11.  Dhoru MM, Parikh MP, Detholia KK, Patel PJ. DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND TENELIGLIPTIN IN THEIR SYNTHETIC MIXTURE. Indian Drugs. 2023 Feb 1;60(2).

12.  Mandale DA, Shah C, Jatt R. Development and validation of novel RP-HPLC method for the simultaneous determination of Rosuvastatin and Teneligliptin in bulk and in synthetic mixture. International Journal of Pharmaceutical Research. 2021 Jul 1;13(3).

13.  Akabari AH, Gajiwala H, Patel SK, Surati J, Solanki D, Shah KV, Patel TJ, Patel SP. Stability-indicating TLC-densitometric and HPLC methods for simultaneous determination of teneligliptin and pioglitazone in pharmaceutical dosage forms with eco-friendly assessment. Journal of Chromatographic Science. 2025 Feb;63(2):bmae038.

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