Author(s): Abhijith. R. R, Gopalakrishnan. G, Bino Kingsley. R

Email(s): rra@live.in

DOI: 10.52711/0974-360X.2022.00960   

Address: Abhijith. R. R1*, Gopalakrishnan. G2, Bino Kingsley. R3
1Quality Control Department, Terumo Penpol Private Limited, Puliyarakonam PO, Thiruvananthapuram - 695573, Kerala, India.
2Department of Pharmacy, Annamalai University, Tamil Nādu.
3Department of Pharmacy, Elims college of Pharmacy, Tirussur, Kerala.
*Corresponding Author

Published In:   Volume - 15,      Issue - 12,     Year - 2022


ABSTRACT:
HPLC-RID developed a simple, accurate, precise, linear, rugged, and robust method for quantifying dextrose in Citrate Phosphate Dextrose (CPD) anticoagulant solution. Despite the fact that there are techniques for simultaneous estimation of dextrose and phosphate by RP-HPLC and measurement of sugars and polyols by HPLC-RID, there was no methods in the literature for measuring Dextrose in Citrate Phosphate Dextrose (CPD) anticoagulant solutions. The current work designed and validated a simple HPLC-RID technique using the C18 column (7.8mm x 30cm x 9µm) with degassed water as the mobile phase. Using a refractive index detector, the flow rate was adjusted to 0.3 mL/min, the column oven temperature was at 85°C, and the detector cell temperature was set to 85°C. The dextrose run time was set to 30 min, and the dextrose was eluted at 20.294 min. The developed method has excellent linearity for dextrose in a wide concentration range (18.6mg/mL – 27.8mg/mL) with an R2 of 0.9981. For five analytes, the limits of detection (LOD) and limits of quantification (LOQ) were 3.9mg/mL and 11.9mg/mL, respectively. The HPLC-RID method demonstrated excellent repeatability (RSD 5%) and reproducibility. Changes in chromatographic conditions were used to test robustness. Even when subjected to modest changes in regular analysis, the technique was shown to be resilient and useful. Specificity, accuracy, precision, linearity, range, ruggedness, and robustness were all validated for the proposed method. The developed method has the potential to be used for quantitative analysis of dextrose in anticoagulant solutions.


Cite this article:
Abhijith. R. R, Gopalakrishnan. G, Bino Kingsley. R. Analytical Method Development and Validation for the Estimation of Dextrose in Citrate Phosphate Dextrose Anticoagulant Solution by HPLC-RID. Research Journal of Pharmacy and Technology 2022; 15(12):5695-9. doi: 10.52711/0974-360X.2022.00960

Cite(Electronic):
Abhijith. R. R, Gopalakrishnan. G, Bino Kingsley. R. Analytical Method Development and Validation for the Estimation of Dextrose in Citrate Phosphate Dextrose Anticoagulant Solution by HPLC-RID. Research Journal of Pharmacy and Technology 2022; 15(12):5695-9. doi: 10.52711/0974-360X.2022.00960   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-12-54


REFERENCES:
1.    Harter K, Levine M, Henderson SO. Anticoagulation drug therapy: a review. The Western Journal of Emergency Medicine. 2015 Jan12;16(1):11-7. doi: 10.5811/westjem.2014.12.22933.
2.    https://go.drugbank.com/drugs/DB09341.
3.    Raina Hadjikinova, Nadezhda Petkova, Dimitar Hadjikinov, Panteley Denev, Dimitar Hrusavov. Development and Validation of HPLC-RID method for Determination of Sugars and Polyols. Journal of Pharmaceutical Sciences and Research. 2017; 9(8): 1263-69.
4.    Ajithkumar KC, Pramod, K. Development and validation of a modified polarimetric assay method for small volume samples. International Journal of Applied Pharmaceutics. 2017 Nov 7;9(6): 91-4.doi:10.22159/ijap.2017v9i6.22459.
5.    Alok K Singh and Amrish Chandra. Analytical Method Development and Validation for the Simultaneous Estimation of Phosphate and Dextrose Content by RP-HPLC in Cabazitaxel Injection, Indo American Journal of Pharmaceutical Science. 2018 March;5(3):1618-26. doi: 10.5281/zenodo.1207359.
6.    Ayalew Debebe, Shibru Temesgen, Mesfin Redi-Abshiro, Bhagwan Singh Chandravanshi and Estifanos Ele. Improvement in Analytical Methods for Determination of Sugars in Fermented Alcoholic Beverages. Journal of Analytical Methods in Chemistry. 2018 Oct; Article ID 4010298,10 pages. doi:10.1155/2018/4010298.
7.    Noe CR, Lachmann B, Möllenbeck S and Richter P. Determination of reducing sugars in selected beverages by capillary electrophoresis. European Food Research and Technology. 1999; 208:148–52.doi:10.1007/s002170050392.
8.    ICH, Q2A, Text on Validation of Analytical Procedures, International Conference on Harmonization. Geneva, 1994:1-5.
9.    ICH, Q2B, Text on Validation of Analytical Procedures: Methodology, International Conference on Harmonization. Geneva, 1996: 1-8.
10.    Peethala Prathyusha, Raja Sundararajan, Palyam Bhanu, Mathrusri Annapurna Mukthinuthalapati. A new stability indicating RP-HPLC method for determination of Bilastine in bulk and pharmaceutical formulation. Research J. Pharm. and Tech. 2020; 13(6): 2849-2853. doi: 10.5958/0974-360X.2018.00572.3.
11.    Sunkara Mrunal Chaithanya, Mukthinuthalapati Mathrusri Annapurna. Method Development and Validation of a new RP-HPLC method for the simultaneous Assay of Ketorolac Tromethamine and Fluorometholone. Research J. Pharm. and Tech. 2018;11(7):3119-22. doi:10.5958/0974-360X.2018.00249.4.
12.    Murugan S, Upendra Janardhan CH, Niranjan Babu M. RP-HPLC Method for Simultaneous Estimation of Albendazole and Niclosamide in Oral Suspension for Veterinary Use. Research J. Pharm. and Tech. 2016; 9(1): 27-32. doi:10.5958/0974-360X.2016.000006.8.
13.    Richa A. Dayaramani, Paresh U. Patel, N. J. Patel. Development and Validation of RP-HPLC Method for Estimation of Stavudine in Bulk and in Capsule Formulation. Research J. Pharm. and Tech. 2020; 13(1):15-21. doi:10.5958/0974-360X.2020.00003.7
14.    Vinyas M, Swapna Velivela, Gopi Yadav, Nikunja B Pati, VRM Gupta. Analytical Method Development and Validation of Alogliptin by RP-HPLC Method. Research J. Pharm. and Tech. 2016; 9(7):775-78. doi:10.5958/0974-360X.2016.00148.7.
15.    Parameswari SA, Ankinapalli AKR, Tsefaye T and Alagusundaram M. Stability indicating RP-HPLC method development and validation for the simultaneous estimation of darunavir, cobicistat, emtricitabine and tenofovir alafenamide in bulk and pharmaceutical formulation. Int J Pharm Sci and Res. 2021; 12(6):3216-24. doi:10.13040/IJPSR.0975-8232.12(6).3216-24.
16.    Atish Z. Dhadve, Anupama R. Dashetwar, Dipak P. Kardile, Rajkumar V. Shete. Stability Indicating RP-HPLC Method for Simultaneous Determination of Atorvastain and Nicotinic acid from Tablet Dosage Form. Research J. Pharm. and Tech. 2020; 13(2):604-608.
17.    Sankar ASK, Datchayani B, Balakumaran B, Mohammed Rilwan, Subaranjani R. Development of a Validated Reverse Phase Liquid Chromatographic Assay-Method for determination of Tofacitinib in pure form and in Physical Admixtures. Research J. Pharm. and Tech. 2017; 10(1): 223-226. doi:10.5958/0974-360X.2017.000047.6.
18.    Bhagwat G B, Jaybhaye Manoj. Development and validation of a RP-HPLC method for the simultaneous estimation of Prochlorperazine maleate and pyridoxine hydrochloride in combined dosage forms. Research J. Pharm and Tech. 2018; 11(4): 1338-42.doi:10.5958/0974-360X.2018.00249.4.
19.    Haneef MA, Rajkamal A, Tharun gouda G, Mohan Goud V. Development and Validation by RP-HPLC Method for Estimation of Zidovudine in bulk and its Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry. 2013 April; 6(4): 341-44. doi: 10.5958/0974-4150.

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 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available