Author(s): Kanchan Jagtap, Sejalben Patel, Ujashkumar Shah

Email(s): mandlikkanchan24@gmail.com

DOI: 10.52711/0974-360X.2023.00025   

Address: Kanchan Jagtap*, Sejalben Patel, Ujashkumar Shah
Department of Pharmaceutical Science, Nootan Pharmacy College, Sankalchand Patel University,Visnagar-384315, Gujarat, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 1,     Year - 2023


ABSTRACT:
We have developed and validated an inexpensive, selective, simple, and precise HPLC-RP dissolution method for estimating the concentration of Metformin and Teneligliptin in combination dosage form. This experimental analysis was performed on a reverse phase high performance high-performance liquid chromatography, (RP-HPLC) column (250mm x 4.6mm, 5µm) by using Mobile phase Acetonitrile and Potassium Dihydrogen Phosphate with concentration 0.05 M and buffer with pH-7.0 at a flow rate of 1.0ml/min and the detected at wavelength 225nm. In line with ICH guidelines, the linearity of the analytical method was discovered to be in the range of 7.0 to 21.00g/ml for Metformin. The linearity of the method for Teneligliptin was 22.5-67.5g/ml. Metformin and Teneligliptin had correlation coefficients greater than 0.990. The relative standard deviation value for system precision and method was less than 2.0%. All statistical data proves validity of the method and can be used for routine analysis of pharmaceutical dosage form.


Cite this article:
Kanchan Jagtap, Sejalben Patel, Ujashkumar Shah. Dissolution Method development and validation for simultaneous determination of Metformin and Teneligliptin in pharmaceutical tablets. Research Journal of Pharmacy and Technology 2023; 16(1):133-9. doi: 10.52711/0974-360X.2023.00025

Cite(Electronic):
Kanchan Jagtap, Sejalben Patel, Ujashkumar Shah. Dissolution Method development and validation for simultaneous determination of Metformin and Teneligliptin in pharmaceutical tablets. Research Journal of Pharmacy and Technology 2023; 16(1):133-9. doi: 10.52711/0974-360X.2023.00025   Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-1-25


REFERENCES:
1.    O’Hara T, Dunne A., Butler J, Devane, J. review of methods used to compare dissolution profile data. Pharmaceutical Science and Technology Today. 1998 Aug; 1(5): 214-223.  
2.    Browen WE, Wang Q, Wuelfing WP, Thomas DL et al. A Biopharmaceutical Classification System Approach to Dissolution: Mechanism and Strategies. Biopharmaceutics Applications in Drug Development. Springer, Boston, MA. 2008; pp. 290-316. doi.org/10.1007/978-0-387-72379-2_9
3.    Lauren C, Vaucher CS, Paim AD, Lange E and Schapoval S. Development and validation of a dissolution test for telithromycin in coated tablets. Quím. Nova. 2009 July; 32(5). doi.org/10.1590/S0100-40422009000500041
4.    Katzung BG, Masters SB, Trevor AJ. Basic and clinical pharmacology Edited by McGraw Hill Medical, New York. 2015; 13th ed; pp. 736–742.
5.    Bichala PK, Kumar KJ,Suthakaran R and Shankar Ch. Development and Validation of an Analytical Method for the Estimation of Metformin and Teneligliptin in its Bulk and Tablet Dosage Form by using RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2020 Jan- Mar; 10(1): 11-14. doi: 10.5958/2231-5675.2020.00003.4.
6.    Upadhyay Y, Sharma N, Sarma GS and Rawal RK. Application of RP–HPLC method in dissolution testing and statistical evaluation by NASSAM for simultaneous estimation of tertiary combined dosages forms. Journal of Pharmaceutical Analysis. 2015October; 5(5): 307–315. doi.org/10.1016/j.jpha.2014.11.001
7.    Salve PM, Sonawane SV, Patil MB and Surawase RK. Dissolution and Dissolution Test Apparatus: A Review. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3):229-236.
8.    Pinaz A. Kasad, K.S. Muralikrishna. Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form. Asian J. Pharm. Ana. 2013 July-Sept.; 3(3): 75-78.
9.    Sen AK, Hinsu DN , Sen DB, Zanwar AS, Maheshwari RA and Chandrakar VR. Analytical method development and validation for simultaneous estimation of Teneligliptin hydrobromide hydrate and Metformin hydrochloride from it’s pharmaceutical dosage form by three different UV spectrophotometric methods. Journal of Applied Pharmaceutical Science. 2016 Sept 6; 6 (09): 157-165. doi: 10.7324/JAPS.2016.60924.
10.    Joshi H and Khristi A. RP-HPLC method development and validation for the simultaneous estimation of Teneligliptine hydrobromide hydrate (ten) and Metformin hydrochloride (met) in tablet dosage form. Indian Drugs. 2019; 56(8): 49– 56.
11.    Lokhande DP. Analytical method development and validation of Teneligliptin by using RP-HPLC with ICH guidelines, International Journal of trend in scientific research and development. 2019 Mar-Apr; 3(3): 259–263. doi: https://doi.org/10.31142/ijtsrd21735
12.    Patel KB, Joshi HV, Shah UA and Patel JK. Development and validation of analytical method for simultaneous estimation of Teneligliptin Hydrobromide Hydrate and Metformin Hydrochloride in pharmaceutical dosage form. Pharma Science Monitor. 2017 Oct-Dec; 8(4): 124-136.
13.    Pawar J, Sonawane S, Chhajed S and Kshirsagar S. Development and Validation of RP-HPLC method for simultaneous Estimation of Metformin HCl and Gliclazide. Asian Journal of Pharmaceutical Analysis. 2016; 6(3): 151-154.
14.    Gadge SS, Nakod AD, Wasnik VP, Gatkine TM et al. Development and Validation of Q-absorbance Ratio method for Simultaneous Estimation of Teniligliptin hydrobromide and Metformin HCl in Multicomponent Dosage Form. Asian Journal of Pharmaceutical Analysis. 2019; 9(4): 215-218.
15.    Farkade K and Tawar M. Analytical Method Validation and Quantitative Analysis for Active Pharmaceutical Ingredient and Marketed Formulation of Teneligliptin Hydrobromide by UV Spectroscopy. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):195-8.
16.    Srivastav A, Tiwari P and Maheshwari S. Development and Validation of Simultaneous Equation UV-Spectrophotometric Method for the Estimation of Metformin HCl and Glimepiride in Combined Dosage Form. Asian Jornal of Research in Chemistry. 2013; 6(9): 845-848.
17.    Hemke AT, Ghuge YG and Gupta KR. Application of RP-HPLC and UV-Spectrophotometric Method in Dissolution Testing of Teneligliptin. Der Pharma Chemica, 2018; 10(1): 103-110.
18.    ICH. Validation of analytical procedures: text and methodology Q2(R1). International Conference on Harmonisation, IFPMA, Geneva. Step 4 of ICH process. 2005: 1-13.
19.    Kumar C, Kumar M, Saini V et al. Dissolution Method Development and Validation for Combination Dosage Form of Telmisartan and Nebivolol hydrochloride Tablets using UV Spectrophotometric Method. Research J. Pharm. and Tech. 2019; 12(6): 2742-2747.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

1.3
2021CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank

Journal Policies & Information


Recent Articles




Tags


Not Available