ABSTRACT:
Voriconazole is anti-fungal agent. Voriconazole is used for treating invasive candidiasis, invasive aspergillosis and emerging fungal infections. A new stability indicating RP-UFLC method has been proposed for the quantification of Voriconazole in pharmaceutical formulations and the method was validated as per ICH guidelines. Mobile phase consisting of a mixture of Acetonitrile: 0.01% Acetic acid (50: 50, v/v) (pH 5.0) with a flow rate 1 mL/min and UV detection at 240 nm was used for the assay of Voriconazole. The drug was exposed to different stress conditions such as alkaline, acidic, thermal and oxidation degradation. Linearity was observed over the concentration range 0.5-50 µg/mL with linear regression equation y = 23554x- 774.8 (r2 = 0.9999). The LOQ and LOD were found to be 0.3987 µg/mL was found to be 0.1313 µg/mL. The present method can be useful for the quantification of pharmaceutical formulations such as tablets and injections and also for the bioanalytical studies.
Cite this article:
Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. Development and validation a new stability indicating RP-UFLC method for the quantification of Voriconazole. Research J. Pharm. and Tech. 2021; 14(1):420-426. doi: 10.5958/0974-360X.2021.00076.7
Cite(Electronic):
Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. Development and validation a new stability indicating RP-UFLC method for the quantification of Voriconazole. Research J. Pharm. and Tech. 2021; 14(1):420-426. doi: 10.5958/0974-360X.2021.00076.7 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-1-76
REFERENCES:
1) Thompson GR and Lewis JS. Pharmacology and clinical use of Voriconazole. Expert Opinion Drug Metabolism Toxicology. 2010; 6(1): 83-94.
2) Pascual A, Calandra T, Bolay S, Buclin T, Bille J and Marchetti O. Voriconazole therapeutic drug monitoring in patients with invasive mycoses improves efficacy and safety outcomes. Clinical Infectious Diseases 2008; 46(2): 201-211.
3) Denning DW, Ribaud P, Milpied N, Caillot D, Herbrecht R, Thiel E, Haas A, Ruhnke M, Lode H. Efficacy and safety of Voriconazole in the treatment of acute invasive aspergillosis. Clinical Infectious Diseases 2002; 34(5): 563-571.
4) Purkins L, Wood N, Greenhalgh K, Allen MJ, Oliver SD Voriconazole, a novel wide-spectrum triazole: oral pharmacokinetics and safety. Brazilian Journal of Clinical Pharmacology. 2003; 56 (Suppl 1): 10-16.
5) Srinu Babu G and Raju ChAI. UV-Spectrophotometric Determination of Voriconazole in bulk and its formulation. Asian Journal of Chemistry. 2007; 19(2): 1625-1627.
6) Anu rekha J, Deepika M, Vidyasagar P and Anirudh J. UV-Spectrophotometric estimation of Voriconazole in bulk and tablet dosage form. Asian Journal of Chemistry. 2009; 21(2): 1627-1629.
7) Subhadip R, Ravi Kumar BVV, Saswati T. Development and validation of new analytical method for Voriconazole by using UV-spectrophotometry. International Journal of Pharmacy & Technology. 2011; 3(1): 1904-1912.
8) Deepan T, Alekhya V, Senniappan P and Dhanaraju MD. Method development and validation for the estimation of Voriconazole by UV-Spectroscopy. International Journal of Chemical and Pharmaceutical Sciences. 2014; 5(2): 164-167.
9) Tamilselvi N, Hassan B, Fadul Fagir B, Deepthi P, Anusha K, Kurian DS. UV-Spectrophotometric analysis of Voriconazole in tablet dosage form. Research Journal of pharmacy and Technology. 2011; 4(11): 1791-1793.
10) Rajasree B and Mathrusri Annapurna M. New spectrophotometric methods for the determination of Voriconazole- An Anti-Fungal Agent. Acta Scientific Pharmaceutical Sciences. 2019; 3(5): 2-7.
11) Dewani MG, Borole TC, SejalP G, Hi, Ashwini RM and Mrinalini CD. Development and Validation of HPTLC method for Determination of Voriconazole in Human Plasma. Der pharma chemical. 2011; 3(4): 201-209.
12) Manali WJ, Atul AS and Sanjay S. RP-HPTLC method for determination of Voriconazole in bulk and in cream formulation. Arabian Journal of Chemistry. 2017; 10(1): S355-S360.
13) Prommas S, Puangpetch A, Jenjirattithigarn N, Chuwongwattana S, Jantararoungtong T, Koomdee N, Santon S, Chamnanphon M, Sukasem C. Development and Validation of Voriconazole Concentration by LC-MS-MS: Applied in Clinical Implementation. Journal of Clinical Lab Analysis. 2017; 31(1): e22011
14) Ping Gu and Yuru Li. Development and validation of stability-indicating HPLC method for determination of Voriconazole and its related substances. Journal of Chromatographic Science. 2009; 47(7): 594-598.
15) Gowri Sankar D, Nagesh Babu A, Rajeswari A and Vamsi Krishna M. RP-HPLC determination of Voriconazole in pure and pharmaceutical dosage forms. Asian Journal of Chemistry. 2009; 21(7): 5015-5018.
16) Shan Cheng, Feng Qiu, Jia Huang, and Junqi He. Development and validation of a simple and rapid HPLC method for the quantitative determination of Voriconazole in rat and beagle dog plasma. Journal of Chromatographic Science. 2007; 45(7): 409-414.
17) Prema. KC, Alpa J. Dherai, and Tester F. Ashavaid. Plasma Voriconazole estimation by HPLC. Indian Journal of Clinical Biochemistry. 2016; 31(2): 209-214.
18) Sreeramamurthy P, Srinivas K, Jogendrakumar YVV, Jagadeesh Panda and Sandhya Rose P. Development and validation of RP-HPLC method for the estimation of Voriconazole in bulk and pharmaceutical dosage form. Chemical Science Transactions. 2017; 3(4): 1576-1582.
19) Peter H. Tang. Quantification of antifungal drug Voriconazole in serum and plasma by HPLC-UV. Journal of Drug Metabolism Toxicology. 2013; 4(2): 2-5.
20) Li GE, Ke-di YANG, Jing SU, Lin-tao TANG and Jie ZHANG. Chiral separation and analysis of Voriconazole enantiomers by HPLC. Chinese Journal of Pharmaceutical Analysis. 2012; 32(11): 1997-2001.
21) Khetre AB, Sinha PK, Mrinalini CD, and Mehendre R. Development and validation of stability indicating RP-HPLC method for Voriconazole. Indian Journal of Pharmaceutical Sciences. 2009; 71(5): 509-514.
22) Srinubabu G, Raju ChAI, Sarath N, KiranKumar P and SeshagiriRao JVLN. Development and validation of HPLC method for determination of Voriconazole in pharmaceutical formulation using an experimental design. Talanta. 2007; 71(3): 1424-1429.
23) ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization, 2005.
24) ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, 2003.