ABSTRACT:
A rapid, accurate, simple, and reproducible UV, HPLC, and stability-indicating spectroscopic method has been developed for the quantitative estimation of Tigecycline in both bulk drug and pharmaceutical dosage forms. A selective, precise, and stability-indicating high-performance liquid chromatography (HPLC) method was established and validated for analyzing Tigecycline in its pharmaceutical formulation. The method was validated in accordance with ICH guidelines to ensure its reliability. HPLC remains the most widely adopted technique for separating, identifying, and quantifying pharmaceutical compounds. To optimize the analytical method, several chromatographic parameters were fine-tuned, including sample preparation, selection of mobile phase, choice of column, and detection system. This paper aims to present a detailed overview of the method development, optimization, and validation procedures.
Mr. Jay, J. Kelvin, and B. Pierre, Understanding and Implementing Efficient Analytical Methods Development and Validation, 2003
2. Ravisankar P, Rajyalakshmi G, Devadasu Ch, and Devala Rao G, Instant tips for right and effective approach to solve HPLC trouble shooting, Journal of chemical and pharmaceutical sciences, 2014; 7(3): 259-274.
3. Jay Breaux, Kevin Jones, and Pierre Boulas, Development services analytical method development and validation Pharmaceutical technology, 2003; 27(1): 6-13.
4. Matthew, Hutchings A, Truman W, Barrie W. Antibiotics: Past, present and future. Current Opinion in Microbiology 2019; 51: 72-80.
5. Tilman CS, Liege, Belgium. Gliptins, dipeptidyl peptidase-4 inhibitors, and risk of acute pancreatitis. Pubmed 2013; 12(4): ): Biosci Res. 2012; 2(2):88-91.
6. Silva LM, Almeida AE, Salgado HR. Thermal analysis and validation of UV and visible spectrophotometric methods for the determination of new antibiotic Tigecycline in pharmaceutical product. Adv Anal Chem. 2012; 2:10-5.
7. M .Akiful Haque, Sandeep Reddy, Gowri Manoja Mulagada, Vasudha Bakshi Development and validation of RP-HPLC method for the estimation of Tigecycline in bulk and its parenteral dosage form. MOL2NET, ICSM 2018
8. Suneetha A, Priyanka GH, Sujitha J. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Tigecycline in Bulk and its Parenteral Dosage Forms. WJPPS. 2017;6(8):1096-107.
9. Hua Xi, Wei Li. Determination of Tigecycline for injection with HPLC. Anhui Medical and Pharmaceutical Journal. 2009; 9.
10. Blessy MR, Patel RD, Prajapat PN, Agrawa YK. Development of forced degÂradation and stability indicating studies of drugs: A review. J Pharm Anal. 2014; 4(3):159-65.
11. Khagga Bhavyasri, Chejati Mounika, M Sumakanth Method Development, Validation and Forced Degradation Studies for Determination of Tigecycline in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy Journal of Young Pharmacists, Vol 12, Issue 2(Suppl), Apr-Jun, 2020
12. Hani Mohammed Hafez , Sona Soliman Barghash, Marwa M. Soliman,Moustafa K. Soltan, Mohamed Abd Elrahman, Noha Salah Katamesh Central composite design driven optimization of sustainable stability indicating HPLC method for the determination of Tigecycline and greenness assessment F1000 Research 2023, 12:341 last updated: 18 AUG 2023
13. Kurien J, Jayasekhar P StabilityIndicating HPLC Determination of Tigecycine in Pharmaceutical Dosage forms IJPRSV-2, I-4, 2013 ISSN No: 2277 – 7873
14. Sharavanan SPN, Venkatesan C.S, Sathiyanarayanan S, Kabilan S. Potential Impurities of tigecycline: synthesis, isolation, characterization and in vitro pharmacological evaluation. Curr Pharm Anal. 2020;16 (6):730-42. doi: 10.2174/ 1573412915666190225160030.
15. Aayesha Ansari, Rashid Ansari, Mohammad Mojeeb Khan. Development and Validation of RP-HPTLC Method for Determination of Tigecycline hydrochloride in Bulk and its Formulation International Journal of Pharmaceutical Research and Applications Volume 9, Issue 4 July Aug 2024, pp: 1444-1449
16. V. N. . Kishore, G. V. Ramana Simultaneous Determination Of Tigecycline And Its Potential Impurities By A Stability-Indicating RP-HPLC -UV Detection Technique Int J App Pharm, Vol 14, Issue 1, 2022, 75-82
17. Kirtimaya Mishra, A Dash, A Jabeen, S.Vegesna, S.K Sahoo, V Gupta, D Jena Chemometric Assisted UV-Spectrophotometric Quantification of Tigecycline in Parenteral Dosage Form IJDDT, Volume 13 Issue 3, July - September 2023
18. RP-HPLC Method Development and Validation for Determination of Tigecycline in Bulk and Pharmaceutical Dosage Form RBVRR women's college of pharmacy, Barkatpura, Hyderabad, between june 2019 and july 2020. Lucélia Magalhães da Silva, Hérida Regina Nunes Salgado, Validation of a Stability-Indicating RP-LC Method for the Determination of Tigecycline in Lyophilized Powder Journal of Chromatographic Science, Volume 51, Issue 2, February 2013, Pages 192–199
19. Rao BV, Sowjanya GN, Ajitha A, Rao Uma MV. A review on stability- indicating HPLC method development, World journal of pharmacy and pharmaceutical sciences, 2015; 4(8): 405-423.
20. Dhirendra Kumar Mehta, Mahato Ashok Kumar, Koiri Sonali HPLC Method Development And Validation: A Review Wjpmr, 2024, 10(1), 233-241 Vol 10, Issue 1, 2024