Volume : 12, Issue : 01, January – 2025
Title:
FORMATION OF NEWER ANALYTICAL METHODS THAT HAVE BEEN VERIFIED FOR DETERMINING IGURATIMOD IN TABLET DOSAGE FORM
Authors :
P. Balakrishanaiah, Afreen Sultana, Ravindar Bairam and Manjunath S.Y
Abstract :
To determine iguratimod, a validated HPLC method was created. 260 nm was used as the detection wavelength. According to ICH criteria, the approach was validated. Over a concentration range of 3–10 µg/mL, linearity was observed (r=0.998). It was discovered that the iguratimod standard solution remained stable for seven hours. Low RSD values demonstrate the accuracy of the developed procedure. The results showed that the LOD and LOQ were 0.1 and 0.3 µg/mL, respectively. Good recovery results indicate that there are no interferences in the procedure. Iguratimod in tablets was effectively determined using this approach. To quantify iguratimod in bulk samples and tablet dosage form, a reversed-phase liquid chromatographic method was created. It was discovered that a water-based system.
Keywords: Iguratimod, linearity, calibration factor, degradation.
Cite This Article:
Please cite this article in press P. Balakrishanaiah et al Formation Of Newer Analytical Methods That Have Been Verified For Determining Iguratimod In Tablet Dosage Form.,Indo Am. J. P. Sci, 2025; 12 (01).
Number of Downloads : 10
References:
1. Shuntaro Takano, Chosaku Yoshida, Takihiro Inaba, Keiichi Tanaka, Ryuko Takeno, Hideyoshi Nagaki, Tomoya Shimotori, 4H-1- benzopyran-4-one derivative or its salt, process for producing the same and pharmaceutical composition comprising the same as active ingredient., Toyama Chemical Company, Ltd., Tokyo, Japan US4954518, 4 Sept, 1990.
2. Wang Jinyi , Li Xudong , Lin Guoqiang ,Zhang Zheng Gen , Wang Lin , Lu Wen bud Preparation of 3-(formamide)-7-(methylsulfonyl amine)-6-(phenoxy)-4H-1-(benzopyran)-4- ketone., Jiangsu Yangtze River Pharmaceutical Group Co. Ltd., CN 1462748.aceutical Group Co. Ltd., CN 1462748.
3. Takihiro Inaba, keiichi Tanaka, ruuko takeno, hideyoshi nagaki, Chosaku Yoshida, Shuntaro takano, Synthesis and Antiinflammatory Activity of 7-Methanesulfonylamino-6- phenoxychromones. Antiarthritic Effect of the 3- Formylamino Compound (T-614) in Chronic inflammatory disease models.Chem. Pharma. Bull, 2000; 48(1): 131-139.
4. Shanghai Huagong, 2008; 32(12): 22-24.
5. Wang Yan Xiang, Gao Hong, Cao Feng hua, Song Dan Qing, Synthesis of Iguratimod Zhongguo Xinyao Zazhi, 2006; 15(23): 2042- 2044.
6. Huagong_Shikan, 2010; 24 (9): 267[1]).
7. Damle MC, Ghode SP, Determination of Iguratimod in Human Plasma by HPLC method, World Journal of Pharmaceutical Research, 2018; 7(14): 404-413. doi: 10.20959/wjpr201814-12892.
8. Zhou T, Ding L, Li X, Zhang F, Zhang Q, Gong B, Guo X, Determination of Iguratimod in rat plasma by High Performance liquid chromatography: method and application, Biomedical Chromatography, 2008; 22(3): 260- 264. doi:https://doi.org/10.1002/bmc.921
9. Han JP, Zhu ZH, Wu YZ, Qian W, Li ZY, Nishikawa M, Sakaki T, Yang CQ, Preparation of a Major Metabolite of Iguratimod and Simultaneous Assay of Iguratimod and Its Metabolite by HPLC in Rat Plasma, Iranian Journal of Pharmaceutical Research,2019;18(2): 631- 641.doi:https://dx.doi.org/10.22037/ijpr.2019.1100641.
10. Xia Y, Zhao S, Gong M, Ding L. A rapid and sensitive LC–MS/MS method for analysis of Iguratimod in human plasma: Application to a pharmacokinetic study in Chinese healthy volunteers, Biomedical Chromatography, 2018; 32(9): e4277.https://doi.org/10.1002/bmc.4277.
11. Kashid, BB, More KR, Sharma B, Ghanwat AA, Identification, Characterization and Synthesis of IguratimodProcess and Degradation Related Impurities, World Journal of Pharmaceutical Research, 2017; 6(14): 1212-1221. doi: 10.20959/wjpr201714-10066.
12. Nehete RB, Sharma P, Development and validation of HPLC method for the Iguratimod, Journal of Harmonized Research in Applied Sciences, 2018;6(1):1-8.doi:https://doi.org/10.30876/johr.
13. Nehete RB, Sharma P, A study of method development and validation for quantification of Iguratimod in pharmaceutical dosage form by RP-HPLC method, Journal of Emerging Technologies and Innovative Research, 2018;5(1):141-50.doi:http://www.jetir.org/papers/JETIR1801027.
14. Nehete RB, Sharma P, Analytical method development and validation for related substance in Iguratimod by HPLC, Journal of Emerging Technologies and Innovative Research, 2018; 5(3):151-7