Author(s): Twinkle Sakariya, Monika Bhaloddiya, Anamik Shah

Email(s): sakariyatwinkle123@gmail.com

DOI: 10.52711/0974-360X.2022.00531   

Address: Twinkle Sakariya, Monika Bhaloddiya, Anamik Shah*
Department of Chemistry, Saurashtra University, Rajkot - 360005, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 7,     Year - 2022


ABSTRACT:
An accurate, precise, robust and selective stability-indicating liquid chromatographic (UPLC) method has been developed for the monitoring of Fidarestat in the presence of its forced degradants. The drug was subjected to hydrolysis (acid and alkali), oxidation, photolysis and thermal stress conditions. The drug degraded significantly under hydrolytic and oxidative stress conditions, whereas it was found to be stable in photolytic and thermal conditions. The mobile phase consisted of 0.1% formic acid and methanol in the ratio of (50:50, v/v). The flow rate was 0.5ml/min, column temperature 30°C, the injec¬tion volume was 20µL, and sample was monitored at 283nm using a PDA detector over a concentration range of 20 - 180µg/ml with correlation coefficient of 0.997. The developed LC method was validated as per ICH guideline Q2 (R1). The proposed method was found to be successively applied for the quality control of Fidarestat in bulk drug analysis.


Cite this article:
Twinkle Sakariya, Monika Bhaloddiya, Anamik Shah. Development of a Stability-indicating RP-UPLC Method for determination of Fidarestat in Bulk Drug. Research Journal of Pharmacy and Technology. 2022; 15(7):3173-8. doi: 10.52711/0974-360X.2022.00531

Cite(Electronic):
Twinkle Sakariya, Monika Bhaloddiya, Anamik Shah. Development of a Stability-indicating RP-UPLC Method for determination of Fidarestat in Bulk Drug. Research Journal of Pharmacy and Technology. 2022; 15(7):3173-8. doi: 10.52711/0974-360X.2022.00531   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-7-53


REFERENCES:
1.    Talluri K., LubnaKhatoon, Kalariya P, ChavanB. LC-MS-MS characterization of forced degradation products of fidarestat, a novel aldose reductase inhibitor: development and validation of a stability-indicating RP-HPLC method. Journal of Chromatographic Science. 2015; 53(9):1588–1596.
2.    Borkar R., Murali M., DubeyA., Nandekar P., SangamwarA., Banerjee S., SrinivasR. Plasma protein binding, pharmacokinetics, tissue distribution and CYP450 biotransformation studies of fidarestat by ultra high-performance liquid chromatography high resolution mass spectrometry. Journal of Pharma and Biomedical Analysis. 2015; 102: 386-399.
3.    Ji-zhong W., Yu-hong R, Ou Ling, Lu-jia Z., Dong-zhiW. Analysis of pharmacokinetics of fidarestat in SD rats by RP-HPLC. ShengwuJiagongGuocheng. 2008; 6: 74-77.
4.    Kuniharu M., Suzuki T., Tanaka T., Taniko K., Suzuki T.  Inhibitory effects of fidarestat on aldose reductase and aldehyde reductase activity evaluated by a new method using HPLC with post-column spectrophotometric detection; Biological and Pharmaceutical Bulletin. 2000; 23(2): 244-248.
5.    Asanoa T., SaitobY., Kawakamic M., YamadadN. Fidarestat clinical pharmacology study group: Fidarestat (SNK-860), A potent aldose reductase inhibitor, normalizes the elevated sorbitol accumulation in erythrocytes of diabetic patients. Journal of Diabetes and its Complications. 2002; 16(2): 133 – 138.
6.    Drel V., Pal P., Ali T., Shin J., Julius U., El-Remessy A., Obrosova I. Aldose reductase inhibitor fidarestat counteracts diabetes-associated cataract formation, retinal oxidativenitrosative stress, glial activation, and apoptosis. International Journal of Molecular Medicine. 2008; 21: 667-676.
7.    Patel M., Kothari C. Review on implementation of multivariate approach for forced degradation study and impurity profiling with regulatory considerations; Chromatographia. 2018; 81(1): 105-125.
8.    Sutar S., Yeligar V., Patil S. A Review: Stability Indicating Forced Degradation Studies. Research J. Pharm. and Tech 2019; 12(2):885-890.
9.    Sutar S., Yeligar V., Patil S. Stability Indicating Forced Degradation Studies. Research J. Pharm. and Tech 2019;12(1): 429-433.
10.    Sri L., Jacob J. Validated degradation studies for the estimation of Pyrazinamide, Ethambutol, Isoniazid and Rifampacin in a fixed dose combination by UPLC. Research J. Pharm. and Tech 2018; 11(7): 2869-2875.
11.    Raul S., Padhy G., Mahapatra A., Charan S. An overview of concept of pharmaceutical validation. Research J. Pharm. and Tech.2014; 7(9): 1081-1090.
12.    Sri D.R., Manikandan A., Rao S.V. Validation of simple isocratic RP-UPLC method for glecaprevir and pibrentasvir determination and its application in the study of stress degradation. Research J. Pharm. and Tech. 2019; 12(9): 4299-4304.
13.    Gupta S.K., Kumar B, Sharma P. Development and validation of a RP-HPLC method for estimation of Thalidomide in solid dosage form. Asian J. Pharm. Ana. 2013; 3(1): 17-19.
14.    Tambe R, Mankar S, Dighe S. Analytical method development and validation of Paliperidone: A Review. Research J. Science and Tech. 2020; 12(1):23-35.
15.    Dighe N., Shinde G, Vikhe J. Simultaneous estimation, validation and force degradation study of Metformin hydrochloride and empagliflozin by RP-HPLC method. Research J. Science and Tech. 2019; 11(2):135-147.
16.    Vekariya N. R., Patel G. F., Dholakiya R. B. Stability- indicating HPTLC determination of Telmisartan in bulk and tablets. Research J. Pharm. and Tech. 2010; 3 (3): 900-904.
17.    Gandla K., N. Ravindra, B. Jyothsna. Development and validation of a reversed-phase HPLC method for simultaneous determination of Aspirin, Atenolol and Amlodipine in capsules dosage forms. Asian J. Pharm. Ana. 2014; 4(3): 116-120.
18.    Nalawade D, Godge R. K., MagarS. D. Analytical method development and validation of Ritonavir: A review. Research J. Science and Tech. 2020; 12(2): 157-162.
19.    Pingale P, SingasaneT. Development and validation of HPLC method for the determination of pregabalin in bulk and in pharmaceutical formulations. Research J. Pharm. and Tech.2012; 5(6): 829-833.
20.    Thangabalan B., Koya A., Chaitanya G., Sunitha N., S. ManoharBabu. Stability indicating RP–HPLC method for the estimation of acamprosate in pure and tablet dosage form. Asian J. Pharm. Ana. 2013; 3(4): 141-146.
21.    SharmaM., Murugesan M. Forced degradation study an essential approach to develop stability indicating method. Journal of Chromatography.2017; 8: 1-3.
22.    ICH, International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use, Validation of analytical procedures: text methodology, Q2 (R1), 2005.
23.    ICH, Analytical procedure development and validation and revision of Q2 (R1) Analytical validation, Q2 (R2), 2018.
24.    ICH, Stability testing of new drug substances and products Q1A (R2), 2003.
25.    ICH, Stability testing: Photostability testing of new drug substances and products Q1B, 1996.

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 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available