Author(s): Bhupender Tomar, Ankita Sharma, Inder Kumar, Sandeep Jain, Pallavi Ahirrao

Email(s): ankitasharma.anks@gmail.com

DOI: 10.52711/0974-360X.2021.00576   

Address: Bhupender Tomar1, Ankita Sharma1*, Inder Kumar2, Sandeep Jain3, Pallavi Ahirrao4
1Department of Pharmaceutical Chemistry, Abhilashi College of Pharmacy, Ner - Chowk, Distt. Mandi (H.P).
2Department of Pharmaceutics, Abhilashi University Chail Chowk Mandi (H.P.).
3Research Scientist Oniosome Healthcare Pvt. Ltd.
4Department of Pharmaceutical Chemistry, Chandigarh College of Pharmacy, Landran, Mohali.
*Corresponding Author

Published In:   Volume - 14,      Issue - 6,     Year - 2021


ABSTRACT:
A simple, precise, and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) was developed and validated for the estimation of the combination of 5- Fluorouracil (5-FU) and Imiquimod in active pharmaceutical ingredients (APIs). The method was carried out on Phenomenex C18 (250 × 4.6mm I.D., 5??m) using isocratic elution mode. The mobile phase was used as Acetonitrile: 10mM potassium dihydrogen orthophosphate: triethylamine (40:59.9:0.1, v/v, pH 4.5 with orthophosphoric acid) and Water: ACN (50:50 v/v) was used as a diluent. The concentration of solvents was 1-20µg/ml and the volume of injection was 20µl with the flow rate of 1.2ml/min. The retention times for 5-FU and Imiquimod were found to be 1.9±0.5 and 6.6±0.5 min respectively. The absorption maxima of 5FU and Imiquimod were found 267nm and 227nm respectively. The method was validated as per ICH guidelines. All the data were found within the specified limits. The limit of detection (LOD) and limit of quantification (LOQ) of 5- Fluorouracil were found to be 0.015µg/mL and 0.048 µg/mL, respectively, and Imiquimod was found to be 0.078µg/mL and 0.237µg/mL, respectively. The method developed in the present study was found to be sensitive, specific, and precise and can be applied for the simultaneous estimation of 5-FU and Imiquimod.


Cite this article:
Bhupender Tomar, Ankita Sharma, Inder Kumar, Sandeep Jain, Pallavi Ahirrao. Development and Validation of the Analytical method for the estimation of a combination of 5-fluorouracil and Imiquimod by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(6):3313-8. doi: 10.52711/0974-360X.2021.00576

Cite(Electronic):
Bhupender Tomar, Ankita Sharma, Inder Kumar, Sandeep Jain, Pallavi Ahirrao. Development and Validation of the Analytical method for the estimation of a combination of 5-fluorouracil and Imiquimod by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(6):3313-8. doi: 10.52711/0974-360X.2021.00576   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-66


REFERENCES:
1.    United States Pharmacopoeia and National Formulary, (24th) Asian Edition, The United States Pharmacopoeia Convention Inc. U.S.A. 2126.
2.    National Center for Biotechnology Information. PubChem Database. 5-Fluorouracil, CID=3385, https://pubchem.ncbi.nlm.nih.gov/compound/5-Fluorouracil (accessed on Apr. 11, 2020)
3.    National Center for Biotechnology Information. PubChem Database. Imiquimod, CID=57469, https://pubchem.ncbi.nlm.nih.gov/compound/Imiquimod (accessed on Apr. 11, 2020)
4.    MS Charde, AS Welankiwar and Kumar J. Method development by liquid chromatography with validation. International Journal of Pharmaceutical Chemistry. 2014; 4(2): 57-61.
5.    B Sriguru, NP Nandha, AS Vairale, AV Sherikar and V Nalamothu. Development and validation of stability-indicating HPLC method for the estimation of 5- Fluorouracil and related substances in a topical formulation. Int. J. Res. Pharm. Sci. 2010; 1(2): 78-85.
6.    Kumar V, Bharadwaj R, GG, and Kumar S. An Overview on HPLC Method Development, Optimization and Validation process for drug analysis. The Pharmaceutical and Chemical Journal. 2015;2(2): 30-40.
7.    Code Q2A-Text on Validation of Analytical Procedure Step-3 Consensus Guideline, 1994, ICH Harmonised Tripartite Guideline.
8.    Code Q2B- Validation of Analytical Procedure Methodology Step- Consensus Guideline, 1994, ICH Harmonised Tripartite Guideline.
9.    Bhagyasree T, Injeti N, Azhakesan A, and Rao UMV. A review on analytical method development and validation. International Journal of Pharmaceutical Research and Analysis. 2014; 4(8): 444-448.
10.    Mishra PR, Satone D, and Meshram DB. Development and Validation of HPLC Method for the Determination of Alcaftadine in Bulk Drug and its Ophthalmic Solution. J Chromatogr Sep Tech. 2016; 7: 312.
11.    Shyamala, K Nirmala, J Mounika and B Nandini. Validated stability-indicating RP-HPLC method for determination of empagliflozin. Der Pharmacia Lettre, 2016; 8 (2): 457-464
12.    Farhat Alia, Sandip Janab, Ramji Rathoda and Ravendra Vermaa. Development and validation of stability-indicating RP-HPLC method for estimation of Ziprasidone in bulk and their capsule dosage form, Journal of Chemical and Pharmaceutical Research. 2016. 8(3): 137-142
13.    CK Kaushal, and B Srivastava. A process of method development: A chromatographic approach. J. Chem. Pharm. Res. 2010; 2(2): 519-545.
14.    N Toomula, Kumar A, Kumar SD, and Bheemidi VS. Development and Validation of Analytical Methods for Pharmaceuticals. J Anal Bioanal Techniques. 2011; 2(5): 1-4.
15.    BT Bhagyasree, N Injeti, A Azhakesan, and UMV Rao. A review on analytical method development and validation. International Journal of Pharmaceutical Research and Analysis. 2014; 4(8): 444-448.
16.    Sood S, Bala R, and Gill NS. Method development and validation using HPLC technique – A review. Journal of Drug Discovery and Therapeutics. 2014; 2(22): 18-24.
17.    Prathap B, Rao GHS, Devdass G, Dey A, and N Harikrishnan. Review on Stability Indicating HPLC Method Development. International Journal of Innovative Pharmaceutical Research. 2012; 3(3): 229-237.
18.    N Toomula, A Kumar, SD Kumar, and VS Bheemidi. Development and Validation of Analytical Methods for Pharmaceuticals. J Anal Bioanal Techniques. 2011; 2(5): 1-4.
19.    T Bhagyasree, N Injeti, A Azhakesan, and UMV Rao, A review on analytical method development and validation, International Journal of Pharmaceutical Research and Analysis.2014; 4(8): 444-448.
20.    Shrivastava A, and Gupta VB. HPLC: Isocratic or Gradient Elution and Assessment of Linearity in Analytical Methods. J Adv Scient Res. 2012; 3(2): 12-20.

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