ABSTRACT:
RP-HPLC method has been developed for the estimation of Gemigliptin and Metformin Hydrochloride. The quantification was carried out C18 bonded phase i.e. Zorbax Eclipse XDB-C18 (4.6×250mm×5µ) with particle size 5 µ/min an isocratic mode with mobile phase consisting of Methanol: Water (20:80 % v/v). The detection was carried out using UV detector at 233 nm. The solutions of Gemigliptin and Metformin Hydrochloridewere chromatographed at a constant flow rate of 1 ml/min and the retention time of the drug was found to be 2.3 min and5.8 min respectively. The linearity range of Gemigliptin and Metformin Hydrochloride were found to be from 1- 35 µg/ml of Gemigliptin and 2-18 µg/ml of Metformin Hydrochloride. Linear regression coefficient for both drugs was 0.999. As per ICH guideline the method was validated for recovery, Precision, ruggednessand linearity.
Cite this article:
Vaishali P. Shelke. Development and Validation of RP-HPLC Method for the Estimation of Gemigliptin and Metformin Hydrochloride. Asian Journal of Pharmaceutical Analysis. 2021; 11(4):259-2. doi: 10.52711/2231-5675.2021.00044
Cite(Electronic):
Vaishali P. Shelke. Development and Validation of RP-HPLC Method for the Estimation of Gemigliptin and Metformin Hydrochloride. Asian Journal of Pharmaceutical Analysis. 2021; 11(4):259-2. doi: 10.52711/2231-5675.2021.00044 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-4-2
REFERENCES:
1. Dr. KumarGV, Dr. NareshD. Nair AR. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin and Gemigliptin by RP-HPLC Method. IJMPR, 2016;4(6): 321-330
2. Gemigliptin: Http:// Pubchem. Ncbi.Nlm.Nih.Gov/Ge migliptin
3. Wei Zeng, Donald MG, Alison FL, Michael SS. Determination of Sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometry. J. Pharm. Biomed.Anal.2008; 46(3): 534-542.
4. Indian Pharmacopoeia, Government of India, Ghaziabad. The Indian Pharmacopoeia Commission. 2010; 6(2): 1657-1658.
5. Indian Pharmacopoeia, Government of India, Ghaziabad. The Indian Pharmacopoeia Commission. 2014; 7(2): 2186.
6. The United States Pharmacopoeia. US Pharmacopoeial convention. Inc. Rockville, MD. 31st Revision. (2008); 2640.
7. Luhar SV, Patel KR, Dr. Narkhede SB. Stability Study of Gemigliptin and Simultaneous Estimation of Gemigliptin and its Degradation Product by RP-HPLC Method. J Pharm SciBioscientific Res. 2016;6(3):338-346.
8. Dr. Kumar GV, Dr. Naresh D. Nair AR. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin and Gemigliptin by RP-HPLC Method. IJMPR, 2016;4(6): 321-330.
9. Instruction manual model HPLC-1220 Infinity LC, Agilent Technologies.
10. ICH, Q2A, Text on validation of analytical products, International conference on Harmonization, Geneva, October 1994: 1-5.
11. ICH, Q2B, Text on validation of analytical products, International conference on Harmonization, Geneva, November 1996: 1668.