Author(s): Ceema Mathew, Shashikala Metri, D. Vijaya Durga, Syed Sara Afreen

Email(s): nirujose@gmail.com

DOI: 10.52711/0974-360X.2024.00237   

Address: Ceema Mathew*, Shashikala Metri, D. Vijaya Durga, Syed Sara Afreen
Gokaraju Rangaraju College of Pharmacy, Osmania University, Bachupally, Hyderabad 500090, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 4,     Year - 2024


ABSTRACT:
In this manuscript an ultrafast, stability-indicating RP-UPLC method with Waters Acquity UPLC having 2996 PDA detection was developed and validated for the quantification of faropenem in the bulk drug and its tablet formulation. The analysis was performed using End version C18 column powered with Software Empower 2 and a mobile phase of 10mM Ammonium formate buffer (pH=3.5): ACN in the ratio of 65: 35(v/v) in isocratic mode at a flow rate of 0.25mL/min at 313nm as the detection wavelength. The linearity range is 5–50µg/mL, and the linear regression analysis of the calibration plot showed a good linear relationship with R2 = 0.9999. The LOD and LOQ were 213 and 638ng/mL, respectively. The stress conditions include acid, alkali, hydrogen peroxide and UV light. The drug peak was well resolved from the degradation products’ peaks, and thereby, the proposed method can be used for the analysis of stability samples.


Cite this article:
Ceema Mathew, Shashikala Metri, D. Vijaya Durga, Syed Sara Afreen. Development and Validation of an LC/MS Compatible, Stability indicating RP-UPLC Method for Faropenem. Research Journal of Pharmacy and Technology.2024; 17(4):1498-2. doi: 10.52711/0974-360X.2024.00237

Cite(Electronic):
Ceema Mathew, Shashikala Metri, D. Vijaya Durga, Syed Sara Afreen. Development and Validation of an LC/MS Compatible, Stability indicating RP-UPLC Method for Faropenem. Research Journal of Pharmacy and Technology.2024; 17(4):1498-2. doi: 10.52711/0974-360X.2024.00237   Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-4-11


REFERENCES:
1.    Dalhoff A. Nasu T. Okamoto K. β-lactamase stability of faropenem. Chemotherapy. 2003; 49(5): 229-36. doi: 10.1159/000072446
2.    Cielecka-Piontek J. Michalska K. Zalewski P.  Jelińska A. Recent advances in stability studies of carbapenems. Current Pharmaceutical Analysis.  2011; 7(4): 213-27. DOI:10.2174/157341211797457989
3.    Hamilton-Miller JM. Chemical and microbiological aspect of penem, a distrinct class of Beta-lactams: focus on faropenem. Pharmacotherapy; 2003; 23(11): 1497-507. doi: 10.1592/phco.23.14.1497.31937
4.    Cielecka-Piontek J. Krause A. Paczkowska M. An application of high performance liquid chromatographic assay for the kinetic analysis of degradation of Faropenem. Die Phamazie. 2012; 67(11): 912-16.
5.    Dalhoff A. Janijic N. Echols R. Redefining penems. Biochemical Pharmacology. 2006; 71(7): 1085-95. doi: 10.1016/j.bcp.2005.12.003
6.    National Center for Biotechnology Information (2022). PubChem Compound Summary for CID 65894, Faropenem. Retrieved November 28, 2022 from https://pubchem.ncbi.nlm.nih.gov/compound/Faropenem.
7.    Critchley IA. Brown SD. Traczewski MM. Tillotson GS. Janjic N. National and regional assessment of antimicrobial resistance among community-acquired respiratory tract pathogens identified in a 2005-2006 U.S. Faropenem surveillance study. Antimicrobial Agents and Chemotherapy. 2007; 51(12):4382–89. doi:10.1128/AAC.00971-07
8.    Mushtaq S. Hope R. Warner M. Livermore DM. Activity of faropenem against cephalosporin-resistant Enterobacteriaceae. The Journal of Antimicrobial Chemotherapy. 2007; 59(5):1025-30. doi: 10.1093/jac/dkm063
9.    Milazzo I. Blandino G. Caccamo F. Musumeci R. Nicoletti G. Speciale A. Faropenem, a new oral penem: antibacterial activity against selected anaerobic and fastidious periodontal isolates. The Journal of Antimicrobial Chemotherapy. 2003; 51(3):721-5.  
10.    Nayak S. Pai U. Birla A. Role of Faropenem in Treatment of Pediatric Infections: The Current State of Knowledge. Cureus. 2022;  25; 14(4): e24453. doi: 10.7759/cureus.24453.
11.    Jamili Reddy K. Shanmukha Kumar JV. Vardhan VM. Spectrophotometric methods for the determination of new oral penem (Faropenem) in pure and informulations. Chem Sci Trans. 2013;  2(3): 936-40.
12.    Judyta CP. Derivative spectrophotometry for the determination of Faropenem in the presence of degradation products: an application for kinetic studies. Applied Spectroscopy. 2013; 67(7): 703-8. doi: 10.1366/12-06779
13.    Darji DN. Desai DG. Zanwar A. Sen AK. Seth AK. Development and validation of UV spectroscopy method for the estimation of Faropenem sodium in bulk and dosage form. Pharma Sci. Monitor. 2013; 4(3): 10-17.
14.    Ramakrishna VSN. Vishwottam NK. Wishu S. Koteshwara M. Quantification of Faropenem in human plasma by high performance liquid chromatography. Arzneimittel-Forschung. 2005; 55(12): 762-766.  doi: 10.1055/s-0031-1296927
15.    Shobana KM. Jayesh GP. Ravindra VP. Development and validation of a stability indicating LC method for the determination of Faropenem in pharmaceutical formulations. Chromatographia. 2009; 69(9-10): 1013-8.
16.    Rui X. Jun W. Hua W. Guorong F. Dabing Z. High-throughput determination of Faropenem in human plasma and urine by on-line solid-phase extraction coupled to high-performance liquid chromatography with UV detection and its application to the pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis. 2010; 52(1): 114-121. doi: 10.1016/j.jpba.2009.12.010
17.    Rizwana I. Vanitha Prakash K. Krishna Mohan G. Analytical method development and validation for the estimation of Faropenem in bulk and pharmaceutical formulation using the RP-HPLC method. International Research Journal of Pharmacy. 2012; 3(12):81-3.
18.    Babu GR. Rao AL. Rao JV. Development and validation of RP-HPLC method for quantitative analysis of faropenem in pure and pharmaceutical formulations. International Journal of Pharmaceutical, Chemical & Biological Sciences. 2013; 3(3):949-54.
19.    Gao S. Chen W. Tao X. Miao H. Yang S. Wu R. Determination of Faropenem in human plasma and urine by liquid chromatography-tandem mass spectrometry. Biomedical Chromatography. 2008; 22(1):5-12.  doi: 10.1002/bmc.886
20.    Geetha Bhavani. Akila Devi D. Development and Validation of Stability Indicating UPLC Method for the Simultaneous Estimation of Drugs in Combined Dosage Forms using Quality by Design Approach. Asian J. Pharm. Ana. 2020; 10(3):158-164. doi: 10.5958/2231-5675.2020.00029.0
21.    González-de-Peredo AV. Vázquez-Espinosa M. Carrera C. Espada-BellidoE . Ferreiro-González M. Barbero FG. Palma M. Development of a Rapid UHPLC-PDA Method for the Simultaneous Quantification of Flavonol Contents in Onions (Allium cepa L.). Pharmaceuticals. 2021; 14: 310. https://doi.org/10.3390/ph14040310
22.    Eswarudu MM.  Chinna Eswaraiah M. Prasanna Kumar K. Sudhakar K. Ultra Performance Liquid Chromatography (UPLC): A Preeminent Technique in Pharmaceutical Analysis.. Research J. Pharm. and Tech.  2012; 5(12):1484-89.
23.    Sathish Kumar Konidala. Ramu Samineni. Yamarthi Venkateswara Rao. Jithendra Chimakurthy. Chaitanya Sucharitha Kolakaluri. Vishali Korrapati. Novel RP-UPLC Method Development and Validation for Simultaneous Quantification of Emtricitabine, Tenofovir and Efavirenz in Bulk and Tablet Dosage Forms. Research Journal of Pharmacy and Technology. 2022; 15(7):3141-6. doi: 10.52711/0974-360X.2022.00525
24.    Rajesh Pudi. Mukthinuthalapati Mathrusri Annapurna. New RP-UPLC method for The Simultaneous Determination of Haloperidol and Benzhexol in Tablets. Research Journal of Pharmacy and Technology. 2019; 12(6): 2847 -50. doi: 10.5958/0974-360X.2019.00479.7
25.    Kailash Chander Malik. Manoj Karwa. Gaurav K. Jain. Rohit Dutt. Development and Validation of UPLC-MS/MS Method for the determination of Rivaroxaban in human plasma using Liquid-liquid extraction. Research Journal of Pharmacy and Technology. 2021; 14(6): 3239-43. doi: 10.52711/0974-360X.2021.00563
26.    Alekhya K. Nataraj KS. Pawar AKM. Vaheeda. Quantifying Pomalidomide in Human Plasma Employing UPLC-MS/MS. Research Journal of Pharmacy and Technology. 2023; 16(4): 1806-10. doi: 10.52711/0974-360X.2023.00296
27.    Sunkara Mrunal Chaithanya, Mukthinuthalapati Mathrusri Annapurna. Stability indicating RP-UPLC method for the simultaneous determination of Atorvastatin and Amlodipine. Research Journal of Pharmacy and Technology. 2019; 12(10): 4867-72. doi: 10.5958/0974-360X.2019.00843.6
28.    Madhavi S. Prameela Rani A. Development and validation of RP-UPLC method for simultaneous estimation of Cobicistat and Darunavir. Research Journal of Pharmacy and Technology. 2017; 10(12): 4343-4349. doi: 10.5958/0974-360X.2017.00796
29.    Kunal Bhattacharya. Nongmaithem Randhoni Chanu. Atanu Bhattacharjee. Bhargab Jyoti Sahariah. Chanam Melody Devi. Ripunjoy Bordoloi. Ultra-Performance Liquid Chromatography - An Updated Review. Research Journal of Pharmacy and Technology. 2022; 15(12):5849-3. doi: 10.52711/0974-360X.2022.00987
30.    ICH Harmonised Tripartite Guideline, Q2(R1), Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation, Geneva. 2005;1-13.

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