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Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study

Year 2019, Volume: 23 Issue: 3, 457 - 464, 27.06.2025

Abstract

Zero and first order derivative spectrophotometric methods were developed for the analysis of rilmenidine in pharmaceutical preparations. Absorbances of rilmenidine were measured at 224 nm for the zero order by measuring height of peak from zero and at 223.20 and 230.20 nm for the first order derivative spectrophotometric method by measuring peak to peak height. The linearity ranges were found to be 50-250 µg/mL for zero and first order spectrophotometric method. The developed methods were validated and the analytical parameters of linearity, limit of detection, limit of quantification, accuracy, precision and recovery were evaluated. In addition, Rilmenidine exposed to the stress conditions of acid, base and oxidative in order to calculate to degradation % by developed zero and first order derivative spectrophotometric method.

References

  • [1] Head GA, Chatzivlastou K, Lukoshkova EV, Jennings GL, Reid CM. A novel measure of the power of the morning blood pressure surge from ambulatory blood pressure recordings. Am J Hypertens. 2010;23(10):1074–1081. [CrossRef]
  • [2] Head GA, Reid CM, Shiel LM, Jennings GL, Lukoshkova EV. Rate of morning rise in blood pressure is elevated in hypertensives. Am J Hypertens. 2006;19(10):1010–1017. [CrossRef]
  • [3] Kario K, Ishikawa J, Pickering TG, Hoshide S, Eguchi K, Morinari M, et al. Morning hypertension: the strongest independent risk factor for stroke in elderly hypertensive patients. Hypertens Res. 2006;29(8):581–587. [CrossRef]
  • [4] Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005;365(9455):217–223.
  • [5] Writing Group Members, Mozaffarian D, Benjamin EJ, et al. Executive summary: heart disease and stroke statistics 2016 update: A report from the American Heart Association. Circulation. 2016;133(4):447–454. [CrossRef]
  • [6] Kearney PM, Whelton M, Reynolds K, Whelton PK, He J. Worldwide prevalence of hypertension: a systematic review. J Hypertens. 2004;22:11–19.
  • [7] Cappuccio FP, Miller MA. Cardiovascular disease and hypertension in sub-Saharan Africa: burden, risk and interventions. Intern Emerg Med. 2016;11:299–305. [CrossRef]
  • [8] Mohammed NM, Sher Abdo HR, Hassan HM. Method development and validation of simultaneous determination of hydrochlorothiazide and losartan in tablet dosage form by RP-HPLC. Int J Pharm Sci & Res. 2019;10(1):227-231. [CrossRef]
  • [9] Mahrouse MA. Simultaneous ultraperformance liquid chromatography/tandem mass spectrometry determination of four antihypertensive drugs in human plasma using hydrophilic-lipophilic balanced reversed-phase sorbents sample preparation protocol. Biomed Chromatogr. 2018;32(12):e4362. [CrossRef]
  • [10] Magdy R, El-Khatib AH, Hemdan A, Elaziz QA, Farouk M, Linscheid MW. Comparative pharmacokinetics of trandolapril, its active metabolite, and verapamil in human plasma of Egyptian population using HPLC-MS/MS. Drug Test Anal. 2018;10(7):1158-1167. [CrossRef]
  • [11] Babarahimi V, Talebpour Z, Haghighi F, Adib N, Vahidi H. Validated determination of losartan and valsartan in human plasma by stir bar sorptive extraction based on acrylate monolithic polymer, liquid chromatographic analysis and experimental design methodology. J Pharm Biomed Anal. 2018;153:204-213. [CrossRef]
  • [12] Santala EE, Rannikko A, Murtola TJ. Antihypertensive drugs and prostate cancer survival after radical prostatectomy in Finland—A nationwide cohort study. Int J Cancer. 2019;144(3):440-447. [CrossRef]
  • [13] Reid JL. Rilmenidine: a clinical overview. Am J Hypertens. 2000;13(6 Pt 2):106S-111S. [CrossRef]
  • [14] PubChem, Open Chemistry Database. Available from: http://pubchem.ncbi.nlm.nih.gov (Accessed: January 4, 2019).
  • [15] Sweetman SC (ed.). Martindale: The Extra Pharmacopoeia, pp. 996, 34th edition. London: The Pharmaceutical Press; 2005.
  • [16] Servier. Summary of product characteristics: Hyperium. Available from: http://www.servier.com. (Accessed: January 31, 2019).
  • [17] Chytil L, Cvacka J, Marešová V, Štrauch B, Widimský J, Štícha JM, Slanará O. Development of a fast LC-MS/MS method for quantification of rilmenidine in human serum: elucidation of fragmentation pathways by HRMS. J Mass Spect. 2010;45:1179-1185. [CrossRef]
  • [18] Ambadas RR, Swapnil RB. First-order derivative spectrophotometric estimation of nabumetone and paracetamol in tablet dosage form. Pharm Methods. 2011;2(4):260-263. [CrossRef]
  • [19] Ojeda CB, Rojas FS. Recent developments in derivative ultraviolet/visible absorption spectrophotometry. Anal Chim Acta. 2004;518:1-24. [CrossRef]
  • [20] International Conference on Harmonization. Stability Testing of New Drug Substances and Products, in: International Conference on Harmonization, 1993.
  • [21] Rojas FS, Ojeda CB, Pavon JM. Derivative ultraviolet—visible region absorption spectrophotometry and its analytical applications. Talanta. 1988;35:753-761. [CrossRef]
  • [22] Karpińska J. Derivative spectrophotometry—recent applications and directions of developments. Talanta. 2004;64:801-822. [CrossRef]
  • [23] Shirkhedkar AA, Bhirud HC, Surana JS. Application of UV-spectrophotometric methods for estimation of tenofovir disoproxil fumarate in tablets. Pak J Pharm Sci. 2009;22:27-29.
  • [24] Jenee C, Purvi S, Margi P, Kalpana P, Tejal G. Optimizing derivatization conditions using an experimental design and simultaneous estimation of artemether and lumefantrine by ratio first order derivative spectrophotometric method. J Taibah Univ Sci. 2017;11:729-740. [CrossRef]
  • [25] Dimal AS, Dixita JS, Chirag ND, Usman KC, Kashyap KB. Estimation of ibuprofen and famotidine in tablets by second order derivative spectrophotometry method. Arab J Chem. 2017;10:105-108. [CrossRef]
  • [26] International Conference on Harmonization. ICH. Validation of Analytical Procedures: Text and Methodology Q2(R1). 2005.
  • [27] International Conference on Harmonization, ICH. Stability Testing of New Drug Substances and Products Q1A(R2). 2003.
There are 27 citations in total.

Details

Primary Language English
Subjects Pharmaceutical Analytical Chemistry
Journal Section Articles
Authors

Ayça Karasakal

Elif Özdemir This is me

Publication Date June 27, 2025
Published in Issue Year 2019 Volume: 23 Issue: 3

Cite

APA Karasakal, A., & Özdemir, E. (2025). Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study. Journal of Research in Pharmacy, 23(3), 457-464.
AMA Karasakal A, Özdemir E. Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study. J. Res. Pharm. June 2025;23(3):457-464.
Chicago Karasakal, Ayça, and Elif Özdemir. “Development and Validation of First and Zero Order Derivative Spectrophotometric Methods for the Determination of Rilmenidine in Pharmaceutical Preparations and Forced Degradation Study”. Journal of Research in Pharmacy 23, no. 3 (June 2025): 457-64.
EndNote Karasakal A, Özdemir E (June 1, 2025) Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study. Journal of Research in Pharmacy 23 3 457–464.
IEEE A. Karasakal and E. Özdemir, “Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study”, J. Res. Pharm., vol. 23, no. 3, pp. 457–464, 2025.
ISNAD Karasakal, Ayça - Özdemir, Elif. “Development and Validation of First and Zero Order Derivative Spectrophotometric Methods for the Determination of Rilmenidine in Pharmaceutical Preparations and Forced Degradation Study”. Journal of Research in Pharmacy 23/3 (June2025), 457-464.
JAMA Karasakal A, Özdemir E. Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study. J. Res. Pharm. 2025;23:457–464.
MLA Karasakal, Ayça and Elif Özdemir. “Development and Validation of First and Zero Order Derivative Spectrophotometric Methods for the Determination of Rilmenidine in Pharmaceutical Preparations and Forced Degradation Study”. Journal of Research in Pharmacy, vol. 23, no. 3, 2025, pp. 457-64.
Vancouver Karasakal A, Özdemir E. Development and validation of first and zero order derivative spectrophotometric methods for the determination of rilmenidine in pharmaceutical preparations and forced degradation study. J. Res. Pharm. 2025;23(3):457-64.