Pterostilbene belongs to phytoalexins group and it is chemically trans 3, 5-dimethoxy-4’-hydroxy-trans-stilbene. Pterostilbene is used for the treatment of diabetes, cancer and fungal infections. A new stability indicating chromatographic method has been developed for the quantification of Pterostilbene and the method was validated. The chromatographic study was studied using Shimadzu Model CBM-20A/20 Alite UFLC system with Sunfire C18 column and PDA detector. A mixture consisting of 0.1M ammonium formate and methanol (15:85, v/v) with flow rate 0.8 mL/min. Linearity was observed over the concentration range 0.05–150 µg/mL (R2 = 0.9999) with linear regression equation y = 207961.521x-16083.7544. The LOD and LOQ were obtained to be 0.01569 µg/mL and 0.04782 µg/mL respectively. Pterostilbene drug solutions were subjected to stress conditions such as acidic, alkaline, oxidation and thermal degradations. The method was validated and can be applied for the quantification of Pterostilbene pharmaceutical formulations.
Cite this article:
Kalyani Lingamaneni, Mukthinuthalapati Mathrusri Annapurna. A new Validated Stability Indicating RP-UFLC Method for the Estimation of Pterostilbene. Research J. Pharm. and Tech 2021; 14(3):1284-1288. doi: 10.5958/0974-360X.2021.00227.4
1. The United States Pharmacopeia. in: USP38-NF33 ed. United States Pharmacopeial Convention INC; 2015. p. 4444.
2. Sweetman SC. Martindale: The Complete Drug Reference. in: 37th ed. Pharmaceutical Press; 2011. p. 1240.
3. Shakya AK, Arafat TA, Hakooz NM, Abuawwad AN, Al-Hroub H, Melhim M. High-performance Liquid Chromatographic determination of montelukast sodium in human plasma: Application to bioequivalence study. Acta Chromatogr. 2014; 26(3): 457–72.
4. Naaz A, Vani R. Simultaneous Estimation of Montelukast and Levocetirizine in Its Bulk and Liquid Dosage form by RP-HPLC. 2015; 5(10).
5. Shrikrishna B, Nisharani R. Analytical Method Development and Validation for Simultaneous Estimation of Montelukast and Ebastine by HPLC. Res J Pharm Technol. 2015; 8(1): 651–8.
6. Chauhan B, Rani S, Nivsarkar M, Padh H. A new liquid-liquid extraction method for determination of montelukast in small volume human plasma samples using HPLC with fluorescence detector. Indian J Pharm Sci. 2009; 68(4): 517.
7. Humaira S, Munde MR, Road OJ. Validated UV Spectroscopic Method for Estimation of. 2010; 01(11): 4–8.
8. Muralidharan S, Jia Qi L, Ting Yi L, Kaur N, Parasuraman S, Kumar J, et al. Newly Developed and Validated Method of Montelukast Sodium Estimation in Tablet Dosage Form by Ultraviolet Spectroscopy and Reverse Phase - High Performance Liquid Chromatography. Pharmacol Toxicol Biomed Reports. 2016; 2(2): 27–30.
9. Patel NK, Chouhan P, Paswan SK, Prakash K. Development and validation of a UV spectrophotometric method for simultaneous estimation of combination of Montelukast sodium in presence of Levocetirizine Dihydrochloride. Paswan [Internet]. 2014; 6(3): 313–21. Available from: http://www.scholarsresearchlibrary.com/articles/development-and-validation-of-a-uv-spectrophotometric-method-for-simultaneous-estimation-of-combination-of-montelukast-s.pdf
10. Tandulwadkar SS, More SJ, Rathore AS, Nikam AR, Sathiyanarayanan L, Mahadik KR. Method Development and Validation for the Simultaneous Determination of Fexofenadine Hydrochloride and Montelukast Sodium in Drug Formulation Using Normal Phase High-Performance Thin-Layer Chromatography. ISRN Anal Chem. 2012; 2012: 1–7.
11. Shakalisava Y, Regan F. Determination of montelukast sodium by capillary electrophoresis. J Sep Sci. 2008 Apr 1; 31:1137–43.
12. Aslan N, Erden PE, Canel E, Kilic E. Development and validation of a potentiometric titration method for the determination of montelukast sodium in a pharmaceutical preparation and its protonation constant. Bulg Chem Commun. 2014; 46(3): 497–502.
13. Alsarra I, Al-Omar M, Gadkariem EA, Belal F. Voltammetric determination of montelukast sodium in dosage forms and human plasma. Farmaco. 2005; 60(6–7): 563–7.
14. Khattab FI, Ramadan NK, Hegazy MA, Ghoniem NS. Microsized Graphite Sensors for Potentiometric Determination of Metronidazole and Spiramycin. Port Electrochim Acta. 2011; 29(2): 79–90.
15. Ion-Selective Electrodes: Recommended Kri. Union Int Pure Appl Chem. 1995; 67(3): 507–18.
16. Haroun M, Nashed D, Sakur AA. New electrochemical methods for the determination of Prasugrel using drug selective membranes. 2017; 5(3): 30–6.
17. Sakur AA, Nashed D, Haroun M, Noureldin I. Determination of prasugrel hydrochloride in bulk and pharmaceutical formulation using new ion selective electrodes. Res J Pharm Technol. 2018; 11(2): 631–6.
18. Mansour O, Nashed D, Sakur AA. Determination of Clopidogrel bisulphate Using Drug Selective Membranes. Res J Pharm Technol. 2018; 11(5).
19. Dabbeet H, Sakur A, Noureldin I. Novel Drug Selective Sensors for Simultaneous Potentiometric Determination of both Ciprofloxacin and Metronidazole in Pure form and Pharmaceutical Formulations. Res J Pharm Technol. 2019 Aug 27; 12: 3377–84.
20. Nashed D, Sakur AA. New Electrochemical Method for Determination of a Compound Derivative from Thienopyridine Using Drug Selective Membranes. has. M.Sc. Thesis in applied analytical chemistry, Faculty of Pharmacy, Aleppo University; Supervisor A.A. Sakur; 2018.
21. Dabbeet HA, Sakur AA. Development of an Electrochemical Method for the Determination of a Compound Derivative from Fluroquinolone. M. Sc. Thesis in applied analytical chemistry, Faculty of Pharmacy, The University of Aleppo; Supervisor A.A. Sakur.; 2016.
22. Nasser B, Mandil H, Sakur AA. Determination of Some Antibiotic (Ciprofloxacin, Norfloxacin and Gatifloxacin) in Pure Form and Pharmaceuticals Formulations Using Electrochemical Titrations. Ph.D. Thesis in applied analytical chemistry, Faculty of Pharmacy, Aleppo University; Supervisor H. Mandil. A.A. Sakur; 2013.
23. Sakur Aa, Bassmajei S, Dabbeet HA. Novel Moxifloxacin Ion Selective Electrodes for Potentiometric Determination of Moxifloxacin in Pure Form and Pharmaceutical Formulations. Int J Acad Sci Res. 2015;3(4): 66–75.
24. Mandil H, A.A. Sakur, Nasser B. New ion selective electrode for potentiometric determination of gatifloxacin in pure form and pharmaceutical formulations. Int J Pharm Pharm Sci. 2013;5(2).
25. Mandil H, Sakur AA, Nasser B. Use of cerium (IV) in potentiometric titration of norfloxacin in pharmaceutical preparations. Asian J Chem. 2012;24(7): 2985–8.
26. International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology, Q2(R1), IFPMA, Geneva. 2005.
27. Babu KP and PS, Department. Validated UV Spectroscopic Method for Estimation of Montelukast Sodium from Bulk and Tablet Formulations. International J Adv Pharmacy, Biol Chem Res. 2012; 1(4): 450–3.