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Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept

Yıl 2022, Cilt: 26 Sayı: 2, 431 - 443, 28.06.2025

Islam Sofiqul Vedigounder Murugan

Öz

A simple and sensitive high-performance liquid chromatographic (HPLC) method is established to separate and quantify the related substance present in two alkylating agents. The use of the traditional approach of analytical validation, in practice or in the literature, is communal. However, statistical verification, that looks separately the two errors (such as absolute bias and repeatability) to make a decision, presents a risk to declare that an analytical method is valid while it is not, or equally. To minimize this peril, a new approach based on the concept of total error was proposed. In this paper, we reveal the applicability and simplicity of the both methods based on the total error approach: accuracy profile and uncertainty profile. Proposed study demonstrated by validation case of a liquid chromatographic LC method for the quantification of related compounds present in two alkylating agents. Both methods showed good linearity response (> 0.995) with repeatability (%relative standard deviation less than 2%) and accuracy (94 to 106%). Accuracy profile was found within the range of ±10% and risk profile ±5% between the two series respectively. The excellence of the total error approach was presented since it enables successfully to validate the analytical procedure as well the calculation of the measurement uncertainty at each concentration level.

Anahtar Kelimeler

Related substances Quantification Total error HPLC Validation

Kaynakça

  • [1] Pereyra CE, Dantas RF, Ferreira SB, Gomes LP, Silva-Jr FP. The diverse mechanisms and anticancer potential of naphthoquinones. Cancer Cell Int. 2019; 19: 207. [CrossRef]
  • [2] Pretty JR, Connor TH, Spasojevic I, Kurtz KS, McLaurin JL, B’Hymer C, Debord DG. Sampling and mass spectrometric analytical methods for five antineoplastic agents in healthcare environment. J Onco Phar Pract. 2012; 18(1): 23-26. [CrossRef]
  • [3] Kung-Tien L, Chien-Hsin C. Determination of impurities in pharmaceuticals: Why and How. Quality Management and quality Control- New Trends and Developments. 2019. [CrossRef]
  • [4] Shivakumar G, Dwivedi J. Identification of degradation products in cyclophosphamide api by LC-QTOF mass spectrometry. J Liq Chromarogr Relat Technol. 2016; 38(2): 190-195. [CrossRef]
  • [5] Arzamastev A, Goizman M, Grishina. A TLC determination of cyclophospahmide degradation products in parent substance and drug preparations. Pharm Chem J. 2004; 37(4): 210-216.
  • [6] Zhou J, Gao S, Zhang F, Jiang B, Zhan Q, Cai F, Li J, Chen W. Liquid- chromatrography tandem mass spectroscopy method for simultaneous determination of seven commonly used anticancer drugs in human plasma. J Chromatogr B. 2012; 906: 1-8. [CrossRef]
  • [7] Sottani C, Rinaldi P, Leoni E, Poggi G, Teragni C, Delmonte A, Minoia C. Simultaneous determination of cyclophosphamide, ifosfamide, doxorubicin, epirubicin and daunorubicin in human urine using HPLC/electrospray ionization tandem mass spectroscopy. Rapid Commun Mass sp. 2008; 22(17): 2645-2649. [CrossRef]
  • [8] Banks CT. The development and applications of coupled HPLC-TLC for pharmaceutical analysis. J Pharm Biomed Anal. 1993; 11(8): 705-710. [CrossRef]
  • [8] Zolezzi C, Ferrari S, Bacci G, Fasano MC, Sormani G, Pizzoferato, A. Determination of ifosfamide by HPLC using on-Line sample preparation. J Chemother. 1999; 11(1): 69-73. [CrossRef]
  • [9] Kerbusch T, Huitema ADR, Jeuken MJJ, Derraz J, Tibben MM, Beijnen JH. Simultaneous determination of ifosfamide and its metabolite Ifosforamide mustard in human plasma by high performance liquid chromatography. J Liq Chromarogr Relat Technol. 2000; 23(19): 2991-2300. [CrossRef]
  • [10] Ahmed M, Usman M, Madni A, Zubai M. A fast and simple HPLC-UV method for simultaneous determination of three anti-cancer agents in plasma of breast cancer patients and its application to clinical pharmacokinetics. Afr J Pharm. 2011; 5(7): 915-922.
  • [11] Larson RR, Khazaeli MB, Dillon HK. Development of an HPLC Method for simultaneous analysis of five antineoplastic agents. Appl Occup Environ Hyg. 2003; 18(2): 109–119. [CrossRef]
  • [12] Rizk M, Taha EA, Mowaka S, Abdallah YM. Validated stability indicating HPLC method for the determination of mesna in presence of its degradation products. J Chromatogr Sci. 2015; 53(5): 742-748. [CrossRef]
  • [13] Sarita M, Jeferson O, Ananda L. Simultaneous determination of cyclophosphamide and ifosfamide in plasma using SPE-HPLC-UV method. Lat Am J Pharm. 2009; 41(6): 41-46.
  • [14] Gibelin N, Dupont D, Imbert S, Rozet E. Use of Total Error concept in the validation of viral activity in cell culture. J Chromatogr B. 2009; 23(1): 2407-2411. [CrossRef]
  • [15] Hoffman D, Kringle R. A total error Approach for the validation of quantitative analysis analytical methods. Pharmaceut Res. 2007; 24(6): 1157-1164. [CrossRef]
  • [16] Traple MAL, Saviano AM, Francisco FL, Lourenço FR. Measurement uncertainty in pharmaceutical analysis and its application. J Pharm Ana. 2014; 4(1): 1-5. [CrossRef]
  • [17] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Geneva, Switzerland, 2005, 1–13.

Yıl 2022, Cilt: 26 Sayı: 2, 431 - 443, 28.06.2025

Islam Sofiqul Vedigounder Murugan

Öz

Kaynakça

  • [1] Pereyra CE, Dantas RF, Ferreira SB, Gomes LP, Silva-Jr FP. The diverse mechanisms and anticancer potential of naphthoquinones. Cancer Cell Int. 2019; 19: 207. [CrossRef]
  • [2] Pretty JR, Connor TH, Spasojevic I, Kurtz KS, McLaurin JL, B’Hymer C, Debord DG. Sampling and mass spectrometric analytical methods for five antineoplastic agents in healthcare environment. J Onco Phar Pract. 2012; 18(1): 23-26. [CrossRef]
  • [3] Kung-Tien L, Chien-Hsin C. Determination of impurities in pharmaceuticals: Why and How. Quality Management and quality Control- New Trends and Developments. 2019. [CrossRef]
  • [4] Shivakumar G, Dwivedi J. Identification of degradation products in cyclophosphamide api by LC-QTOF mass spectrometry. J Liq Chromarogr Relat Technol. 2016; 38(2): 190-195. [CrossRef]
  • [5] Arzamastev A, Goizman M, Grishina. A TLC determination of cyclophospahmide degradation products in parent substance and drug preparations. Pharm Chem J. 2004; 37(4): 210-216.
  • [6] Zhou J, Gao S, Zhang F, Jiang B, Zhan Q, Cai F, Li J, Chen W. Liquid- chromatrography tandem mass spectroscopy method for simultaneous determination of seven commonly used anticancer drugs in human plasma. J Chromatogr B. 2012; 906: 1-8. [CrossRef]
  • [7] Sottani C, Rinaldi P, Leoni E, Poggi G, Teragni C, Delmonte A, Minoia C. Simultaneous determination of cyclophosphamide, ifosfamide, doxorubicin, epirubicin and daunorubicin in human urine using HPLC/electrospray ionization tandem mass spectroscopy. Rapid Commun Mass sp. 2008; 22(17): 2645-2649. [CrossRef]
  • [8] Banks CT. The development and applications of coupled HPLC-TLC for pharmaceutical analysis. J Pharm Biomed Anal. 1993; 11(8): 705-710. [CrossRef]
  • [8] Zolezzi C, Ferrari S, Bacci G, Fasano MC, Sormani G, Pizzoferato, A. Determination of ifosfamide by HPLC using on-Line sample preparation. J Chemother. 1999; 11(1): 69-73. [CrossRef]
  • [9] Kerbusch T, Huitema ADR, Jeuken MJJ, Derraz J, Tibben MM, Beijnen JH. Simultaneous determination of ifosfamide and its metabolite Ifosforamide mustard in human plasma by high performance liquid chromatography. J Liq Chromarogr Relat Technol. 2000; 23(19): 2991-2300. [CrossRef]
  • [10] Ahmed M, Usman M, Madni A, Zubai M. A fast and simple HPLC-UV method for simultaneous determination of three anti-cancer agents in plasma of breast cancer patients and its application to clinical pharmacokinetics. Afr J Pharm. 2011; 5(7): 915-922.
  • [11] Larson RR, Khazaeli MB, Dillon HK. Development of an HPLC Method for simultaneous analysis of five antineoplastic agents. Appl Occup Environ Hyg. 2003; 18(2): 109–119. [CrossRef]
  • [12] Rizk M, Taha EA, Mowaka S, Abdallah YM. Validated stability indicating HPLC method for the determination of mesna in presence of its degradation products. J Chromatogr Sci. 2015; 53(5): 742-748. [CrossRef]
  • [13] Sarita M, Jeferson O, Ananda L. Simultaneous determination of cyclophosphamide and ifosfamide in plasma using SPE-HPLC-UV method. Lat Am J Pharm. 2009; 41(6): 41-46.
  • [14] Gibelin N, Dupont D, Imbert S, Rozet E. Use of Total Error concept in the validation of viral activity in cell culture. J Chromatogr B. 2009; 23(1): 2407-2411. [CrossRef]
  • [15] Hoffman D, Kringle R. A total error Approach for the validation of quantitative analysis analytical methods. Pharmaceut Res. 2007; 24(6): 1157-1164. [CrossRef]
  • [16] Traple MAL, Saviano AM, Francisco FL, Lourenço FR. Measurement uncertainty in pharmaceutical analysis and its application. J Pharm Ana. 2014; 4(1): 1-5. [CrossRef]
  • [17] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Geneva, Switzerland, 2005, 1–13.
Toplam 18 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Farmasotik Kimya
Bölüm Articles
Yazarlar

Islam Sofiqul 0000-0003-3646-9380

Vedigounder Murugan 0000-0002-9893-5669

Yayımlanma Tarihi 28 Haziran 2025
Yayımlandığı Sayı Yıl 2022 Cilt: 26 Sayı: 2

Kaynak Göster

APA Sofiqul, I., & Murugan, V. (2025). Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept. Journal of Research in Pharmacy, 26(2), 431-443.
AMA Sofiqul I, Murugan V. Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept. J. Res. Pharm. Haziran 2025;26(2):431-443.
Chicago Sofiqul, Islam, ve Vedigounder Murugan. “Development of Validation of a Rapid and Simple Analytical Separation Method for Anticancer Alkylating Agents Using Application of Total Error Concept”. Journal of Research in Pharmacy 26, sy. 2 (Haziran 2025): 431-43.
EndNote Sofiqul I, Murugan V (01 Haziran 2025) Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept. Journal of Research in Pharmacy 26 2 431–443.
IEEE I. Sofiqul ve V. Murugan, “Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept”, J. Res. Pharm., c. 26, sy. 2, ss. 431–443, 2025.
ISNAD Sofiqul, Islam - Murugan, Vedigounder. “Development of Validation of a Rapid and Simple Analytical Separation Method for Anticancer Alkylating Agents Using Application of Total Error Concept”. Journal of Research in Pharmacy 26/2 (Haziran 2025), 431-443.
JAMA Sofiqul I, Murugan V. Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept. J. Res. Pharm. 2025;26:431–443.
MLA Sofiqul, Islam ve Vedigounder Murugan. “Development of Validation of a Rapid and Simple Analytical Separation Method for Anticancer Alkylating Agents Using Application of Total Error Concept”. Journal of Research in Pharmacy, c. 26, sy. 2, 2025, ss. 431-43.
Vancouver Sofiqul I, Murugan V. Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept. J. Res. Pharm. 2025;26(2):431-43.