Author(s): Amitkumar J. Vyas, Harshal M. Vadile, Jayshree P. Godhaniya, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Ashvin V. Dudhrejiya, Sunny R. Shah, Urvi J. Chotaliya, Devang B. Sheth

Email(s): harshalvadile8469@gmail.com

DOI: 10.52711/0974-360X.2024.00668   

Address: Amitkumar J. Vyas1, Harshal M. Vadile1*, Jayshree P. Godhaniya1, Chirag D. Jadav1, Ajay I. Patel1, Ashok B. Patel2, Ashvin V. Dudhrejiya1, Sunny R. Shah1, Urvi J. Chotaliya1, Devang B. Sheth3
1B. K. Mody Government Pharmacy College, Rajkot, Gujarat, India, Postal Code: 360003.
2Government Pharmacy College, Gandhinagar, Gujarat, India.
3LM College of Pharmacy, Ahmedabad, Gujarat, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 9,     Year - 2024


ABSTRACT:
This study outlines a method using RP-HPLC to analyze Rosuvastatin calcium and Teneligliptin hydrobromide hydrate. The separation was accomplished at ?(245nm) with a 1mL/min F.R with [KH2PO4 buffer (pH 3): Methanol: Acetonitrile (75:20:5 %v/v)] using a C18 (25 cm x 4.6 mm, 5µm). Both were eluted with retention times of 3.19 min and 2.08 min respectively. Linearity was observed across a defined concentration range for both drugs, with high correlation coefficients. Accuracy of the method was confirmed through analysis of known concentrations, indicating its suitability for routine analysis of these compounds in a synthetic mixture.


Cite this article:
Amitkumar J. Vyas, Harshal M. Vadile, Jayshree P. Godhaniya, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Ashvin V. Dudhrejiya, Sunny R. Shah, Urvi J. Chotaliya, Devang B. Sheth. 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; 17(9):4325-8. doi: 10.52711/0974-360X.2024.00668

Cite(Electronic):
Amitkumar J. Vyas, Harshal M. Vadile, Jayshree P. Godhaniya, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Ashvin V. Dudhrejiya, Sunny R. Shah, Urvi J. Chotaliya, Devang B. Sheth. 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; 17(9):4325-8. doi: 10.52711/0974-360X.2024.00668   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-9-29


REFERENCES:
1.    Indian pharmacopoeia. Government of India. Ghaziabad: Ministry of Health and Family Welfare, Published by theIndian Pharmacopoeia Commission. 2018; Vol-II, 3141.
2.    Lemke TL. Foye’s principles of medicinal chemistry. Edn 7, Walters Kulwer Pvt Ltd, New Delhi, 2013; 877-880.
3.    Drug profile and information of Teneligliptin Hydrobromide Hydrate. November 2020. https://pubchem.ncbi.nlm.nih.gov/compound/Teneligliptin-hydrobromide-hydrate
4.    Ronald MK, Siri PW. Dyslipidemia in type 2 diabetes. Medical Clinics of North America. 2004; 897-909. doi: 10.1016/j.mcna.2004.04.004
5.    Vys AJ et al. Analytical Quality by Design in Stress Testing or Stability - Indicating Method. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 170-178. doi: 10.52711/2231-5675.2022.00023
6.    Vys AJ et al. Stability testing: An Essential study for Vaccine Formulation Development.Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 29-6. doi: 10.52711/2231-5691.2022.00006
7.    Patel AI et al. RP-HPLC method for determination of gemfibrozil using central composite design (CCD). Research Journal of Pharmacy and Technology. 2021; 14(6): 3009-3014. doi: 10.52711/0974-360X.2021.00527
8.    Vys AJ et al. Review on simultaneous equation method (Vierodt's method). Asian Journal of Pharmaceutical Analysis. 2022; 12(2): 149-156. doi: 10.52711/2231-5675.2022.00026
9.    Patel AI et al. Rapid, sensitive and simple LC-MS/MS method development and validation for estimation of phenytoin in human plasma by using deuterated internal standard. Research Journal of Pharmacy and Technology. 2021; 14(6): 2937-2944. doi: 10.52711/0974-360X.2021.00515.
10.    Patel AB et al.  A brief review on genotoxic impurities in pharmaceuticals. Asian Journal of Pharmaceutical Research. 2021; 11(3): 187-193. doi: 10.52711/2231-5691.2021.00034.
11.    Patel AB et al. A Review on Metal Impurities in Pharmaceutical. Asian Journal of Pharmaceutical Analysis. 2021; 11(3): 212-222. doi:10.52711/2231-5675.2021.00038
12.    Vyas AJ et al. A review on carcinogenic impurities found in marketed drugs and strategies for its determination by analytical methods. Asian Journal of Pharmaceutical Analysis. 2021; 11(2): 159-169.
13.    Pandya CB et al. Development and Validation of RP-HPLC Method for Determination of Rosuvastatin Calcium in Bulk and Pharmaceutical Dosage Form. International Journal of Pharmaceutical Science Review and Research. 2010; 82-86.
14.    Hazra K et al. Development and Validation of RP-HPLC Method for Estimation of Rosuvastatin Calcium Solid Dispersions Tablets. Asian Journal of Pharmaceutical Research. 2014; 122-125.
15.    Bansode AS et al. Analytical method development and validation of Teneligliptin hydrobromide in pure form by HPLC.World Journal of Pharmaceutical Sciences. 2017; 37-38.
16.    Lokhande P. Analytical Method Development and Validation of Teneligliptin by using RP-HPLC with ICH Guidelines. International Journal of Trend in Scientific Research and Development. 2019; 259-263. doi:https://doi.org/10.31142/ijtsrd21735
17.    Chitlange SS et al. Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method. Analytical Chemistry Letters. 2017; 556-566. doi: https://doi.org/10.1080/22297928.2017.1364664
18.    V.V. Karkhanis, Vikas Parikh, Roma Panchal. Estimation of Rosuvastatin Calcium in Tablet Dosage Form by HPTLC Method. Asian Journal of Research Chemistry. 2011; 1206-1209.
19.    Raj HA et al. Development And Validation Of Two Chromatographic Stability-indicating Methods for Determination of Rosuvastatin in Pure Form and Pharmaceutical Preparation.International Journal of ChemTech Research. 2009; 677-689.
20.    Shaha Y et al. Determination of Rosuvastatin and Its Metabolite N-desmethyl Rosuvastatin in Human Plasma by Liquid Chromatography–high-Resolution Mass Spectrometry Method Development, Validation and Application to Pharmacokinetic Study.Journal of Liquid Chromatography and Related Technology. 2014; 1-36. doi: https://doi.org/10.1080/10826076.2014.982866
21.    Park JW et al. Development of a liquid chromatography/tandem mass spectrometry assay for the simultaneous determination of Teneligliptin and its active metabolite Teneligliptin sulfoxide in human plasma. Journal of Biomedical Chromatography. 2019. doi: 10.1002/bmc.4721
22.    Maruthi R, Chandan R. S, Anand Kumar Tengli. Characterization of impurities in Teneligliptin hydrobromide hydrate by using LCMS/MS and NMR. Research J. Pharm. and Tech. 2020; 13(8): 3569-3576
23.    Singh H et al. Determination of Rosuvastatin Calcium in Bulk and Pharmaceutical Dosage Forms by Using UV-spectrophotometric Method. Asian Journal of Pharmacy and Pharmacology. 2018; 45-48.doi:10.31024/ajpp.2018.4.1.8
24.    Gupta A, Mishra P, Shah K. Simple UV Spectrophotometric Determination of Rosuvastatin Calcium in Pure Form and In Pharmaceutical Formulations. Journal of Chemistry. 2009; 89-92. doi: https://doi.org/10.1155/2009/956712
25.    Poulami P et al. Novel spectrophotometric method development and validation of Tenagliptin in its Tablet dosages form.Journal of Drug Delivery and Therapeutics. 2019; 95-98. doi: https://doi.org/10.22270/jddt.v9i5.3503
26.    Jain PS et al. UV-AUC Spectrophotometric Method for Quantitative Estimation of Teneligliptin. Acta Scientific Pharmaceutical Sciences. 2019; 43-47. doi: 10.31080/ASPS.2019.03.0274
27.    Kshirsagar SA. UV Spectrophotometric Method Development and Validation for Determination of Teneligliptin Hydrobromide Hydrate in API and Pharmaceutical Dosage Form. International Journal for Pharmaceutical Research Scholars. 2018.
28.    Patel F et al. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Teneligliptin Hydrobromide Hydrate and Rosuvastatin Calcium in Synthetic Mixture. International Journal of All Research Education & Scientific Methods. 2021; 2712-2719.
29.    ICH – Harmonized Tripartite Guideline. Validation of analytical procedures: text and methodology Q2 (R1). International Conference on Harmonization. IFPMA, Geneva, Switzerland, 2005.

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