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The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method

Yıl 2019, Cilt: 23 Sayı: 2, 170 - 176, 27.06.2025

Bediha Akmese Nurgul Karadas Bakirhan , Tuğçe Göver

Öz

Daptomycin is known as the first lipopeptide antibiotic shows activity against gram-positive bacteria. A fast, simple and repeatabile RP-LC method has been developed for the determination of daptomycin in mobile phase solution and human urine. This drug was exposed to various stress conditions such as hydrolytic, oxidative, thermal and photolytic and the stressed samples were detected by the proposed method. Daptomycin was well separated on a X-Terra RP-18 column using the mobile phase consisting of a mixture of acetonitrile:water (45:55 v/v) at a flow rate of 1 mL min-1. The system operates at 222 nm for daptomycin and 319 nm and tinidazole was used as internal standard under these conditions. The linearity of daptomycin was obtained between 0.50 and 12 µg mL-1 concentration range. Limits of detection was determined as 0.1176 and 0.1412 µg mL-1 and the limits of quantification was obtained as 0.3563 and 0.4277 µg mL-1 in the mobile phase and urine, respectively. Hydrochloric acid, sodium hydroxide, hydrogen peroxide affected response of daptomycin under stress degradation conditions.

Anahtar Kelimeler

Drug daptomycin degradation conditions high performance liquid chromatography

Kaynakça

  • [1] Taylor SD, Palmer M. The action mechanism of daptomycin. Bioorg Med Chem. 2016; 24: 6253–6268. [CrossRef]
  • [2] Johnson A. Daptomycin in the treatment of skin, soft-tissue and invasive infections due to Gram-positive bacteria. Future Microbiol. 2006; 1: 255–265. [CrossRef]
  • [3] Ogami C, Tsuji Y, Kasai H, Hiraki Y, Yamamoto Y, Matsunaga K, Karube Y, To H. Evaluation of pharmacokinetics and the stability of daptomycin in serum at various temperatures. Int J Infect Dis. 2017; 57: 38–43. [CrossRef]
  • [4] Wu G, Abraham T, Rapp J, Vastey F, Saad N, Balmir E. Daptomycin evaluation of a high-dose treatment strategy. Int J Antimicrob Agents. 2011; 38: 192–196. [CrossRef]
  • [5] Seaton RA, Menichetti F, Dalekos G, Beiras-Fernandez A, Nacinovich F, Pathan R, Hamed K. Evaluation of effectiveness and safety of high-dose daptomycin: results from patients included in the European Cubicin1 Outcomes Registry and Experience. Adv Ther. 2015; 32(12): 1192–1205. [CrossRef]
  • [6] Deryke CA, Sutherland C, Zhang B, Nicolau DP, Kuti JL. Serum bactericidal activities of high-dose daptomycin with and without co administration of gentamycin against isolates of Staphylococcus aureus and Enterococcus species. Antimicrob Agents Chemother. 2006; 50(11): 3529-3534.
  • [7] Gikas E, Bazoti FN, Fanourgiakis P, Perivolioti E, Roussidis A, Skoutelis A, Tsarbopoulos A. Development and validation of a UPLC-UV method for the determination of daptomycin in rabbit plasma. Biomed Chromatogr. 2009; 24(5): 522-527. [CrossRef]
  • [8] Baietto L, D´Avolio A, Rosa FG, Garazzino S, Michelazzo M, Ventimiglia G, Siccardi M, Simiele M, Sciandra M, Di Perri G. Development and validation of a simultaneous extraction procedure for HPLC-MS quantification of daptomycin, amikacin, gentamicin, and rifampicin in human plasma. Anal Bioanal Chem. 2010; 396(2): 791-798.
  • [9] Christ AP, Machado MS, Rosa P, Codevilla CF, Rolim CMB, Adams AIH. Development and validation of a stability-indication LC-UV method for determination of daptomycin injectable form and kinetic study in alkaline medium. Anal Methods. 2014; 6(4): 1242-1247.
  • [10] Christ AP, Machado MS, Ribas KG, Schwarzbold AV, Silva CB, Adams AIH. A fully validated microbiological assay for daptomycin injection and comparison to HPLC method. Braz J Pharm Sci. 2015; 51-55.
  • [11] ICH guidelines, Q1A(R2): Stability Testing of New Drug Substances and Products (revision 2), International Conference on Harmonization, 2003.
  • [12] Reynolds DW, Facchine KL, Mullaney JF. Available guidance and best practices for conducting forced degradation studies. Pharm Technol. 2002; 26(2): 48–56.
  • [13] Brummer H. How to approach a forced degradation study. Life Sci Technol Bull. 2011; 31: 1–3.
  • [14] Blessy M, Ruchi DP, Prajesh N, Prajapati YK, Agrawal. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014; 4(3): 159–165. [CrossRef]
  • [15] ICH, Stability Testing of New Drug Substances and Products (Q1AR): International Conference on Harmonization, IFPMA, Geneva, 2000.
  • [16] Tambe SR, Shinde RH, Gupta LR, Pareek V, Bhalerao SB. Thin layer chromatography in drug analysis. J Liq Chrom Rel Tech. 2010; 33(4): 423.
  • [17] Ermer J, Miller JH. Method validation in pharmaceutical analysis, 1st Edn. Wiley-VCH Pub, Germany, 2005.
  • [18] Topic Q2A, Validation of Analytical Procedures, Methodology, International Conference on Harmonization, Brussels, Belgium, 1995.
  • [19] Riley CM, Rosanske TW. Development and Validation of Analytical Methods. Amsterdam: Elsevier, 1996.

Yıl 2019, Cilt: 23 Sayı: 2, 170 - 176, 27.06.2025

Bediha Akmese Nurgul Karadas Bakirhan , Tuğçe Göver

Öz

Kaynakça

  • [1] Taylor SD, Palmer M. The action mechanism of daptomycin. Bioorg Med Chem. 2016; 24: 6253–6268. [CrossRef]
  • [2] Johnson A. Daptomycin in the treatment of skin, soft-tissue and invasive infections due to Gram-positive bacteria. Future Microbiol. 2006; 1: 255–265. [CrossRef]
  • [3] Ogami C, Tsuji Y, Kasai H, Hiraki Y, Yamamoto Y, Matsunaga K, Karube Y, To H. Evaluation of pharmacokinetics and the stability of daptomycin in serum at various temperatures. Int J Infect Dis. 2017; 57: 38–43. [CrossRef]
  • [4] Wu G, Abraham T, Rapp J, Vastey F, Saad N, Balmir E. Daptomycin evaluation of a high-dose treatment strategy. Int J Antimicrob Agents. 2011; 38: 192–196. [CrossRef]
  • [5] Seaton RA, Menichetti F, Dalekos G, Beiras-Fernandez A, Nacinovich F, Pathan R, Hamed K. Evaluation of effectiveness and safety of high-dose daptomycin: results from patients included in the European Cubicin1 Outcomes Registry and Experience. Adv Ther. 2015; 32(12): 1192–1205. [CrossRef]
  • [6] Deryke CA, Sutherland C, Zhang B, Nicolau DP, Kuti JL. Serum bactericidal activities of high-dose daptomycin with and without co administration of gentamycin against isolates of Staphylococcus aureus and Enterococcus species. Antimicrob Agents Chemother. 2006; 50(11): 3529-3534.
  • [7] Gikas E, Bazoti FN, Fanourgiakis P, Perivolioti E, Roussidis A, Skoutelis A, Tsarbopoulos A. Development and validation of a UPLC-UV method for the determination of daptomycin in rabbit plasma. Biomed Chromatogr. 2009; 24(5): 522-527. [CrossRef]
  • [8] Baietto L, D´Avolio A, Rosa FG, Garazzino S, Michelazzo M, Ventimiglia G, Siccardi M, Simiele M, Sciandra M, Di Perri G. Development and validation of a simultaneous extraction procedure for HPLC-MS quantification of daptomycin, amikacin, gentamicin, and rifampicin in human plasma. Anal Bioanal Chem. 2010; 396(2): 791-798.
  • [9] Christ AP, Machado MS, Rosa P, Codevilla CF, Rolim CMB, Adams AIH. Development and validation of a stability-indication LC-UV method for determination of daptomycin injectable form and kinetic study in alkaline medium. Anal Methods. 2014; 6(4): 1242-1247.
  • [10] Christ AP, Machado MS, Ribas KG, Schwarzbold AV, Silva CB, Adams AIH. A fully validated microbiological assay for daptomycin injection and comparison to HPLC method. Braz J Pharm Sci. 2015; 51-55.
  • [11] ICH guidelines, Q1A(R2): Stability Testing of New Drug Substances and Products (revision 2), International Conference on Harmonization, 2003.
  • [12] Reynolds DW, Facchine KL, Mullaney JF. Available guidance and best practices for conducting forced degradation studies. Pharm Technol. 2002; 26(2): 48–56.
  • [13] Brummer H. How to approach a forced degradation study. Life Sci Technol Bull. 2011; 31: 1–3.
  • [14] Blessy M, Ruchi DP, Prajesh N, Prajapati YK, Agrawal. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014; 4(3): 159–165. [CrossRef]
  • [15] ICH, Stability Testing of New Drug Substances and Products (Q1AR): International Conference on Harmonization, IFPMA, Geneva, 2000.
  • [16] Tambe SR, Shinde RH, Gupta LR, Pareek V, Bhalerao SB. Thin layer chromatography in drug analysis. J Liq Chrom Rel Tech. 2010; 33(4): 423.
  • [17] Ermer J, Miller JH. Method validation in pharmaceutical analysis, 1st Edn. Wiley-VCH Pub, Germany, 2005.
  • [18] Topic Q2A, Validation of Analytical Procedures, Methodology, International Conference on Harmonization, Brussels, Belgium, 1995.
  • [19] Riley CM, Rosanske TW. Development and Validation of Analytical Methods. Amsterdam: Elsevier, 1996.
Toplam 19 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılıkta Analitik Kimya, Farmasotik Kimya
Bölüm Articles
Yazarlar

Bediha Akmese

Nurgul Karadas Bakirhan

Tuğçe Göver

Yayımlanma Tarihi 27 Haziran 2025
Yayımlandığı Sayı Yıl 2019 Cilt: 23 Sayı: 2

Kaynak Göster

APA Akmese, B., Karadas Bakirhan, N., & Göver, T. (2025). The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method. Journal of Research in Pharmacy, 23(2), 170-176.
AMA Akmese B, Karadas Bakirhan N, Göver T. The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method. J. Res. Pharm. Haziran 2025;23(2):170-176.
Chicago Akmese, Bediha, Nurgul Karadas Bakirhan, ve Tuğçe Göver. “The Development of Forced Degradation Studies for the Determination of Daptomycin in Urine at Various Conditions by Using RP-LC Method”. Journal of Research in Pharmacy 23, sy. 2 (Haziran 2025): 170-76.
EndNote Akmese B, Karadas Bakirhan N, Göver T (01 Haziran 2025) The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method. Journal of Research in Pharmacy 23 2 170–176.
IEEE B. Akmese, N. Karadas Bakirhan, ve T. Göver, “The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method”, J. Res. Pharm., c. 23, sy. 2, ss. 170–176, 2025.
ISNAD Akmese, Bediha vd. “The Development of Forced Degradation Studies for the Determination of Daptomycin in Urine at Various Conditions by Using RP-LC Method”. Journal of Research in Pharmacy 23/2 (Haziran 2025), 170-176.
JAMA Akmese B, Karadas Bakirhan N, Göver T. The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method. J. Res. Pharm. 2025;23:170–176.
MLA Akmese, Bediha vd. “The Development of Forced Degradation Studies for the Determination of Daptomycin in Urine at Various Conditions by Using RP-LC Method”. Journal of Research in Pharmacy, c. 23, sy. 2, 2025, ss. 170-6.
Vancouver Akmese B, Karadas Bakirhan N, Göver T. The development of forced degradation studies for the determination of daptomycin in urine at various conditions by using RP-LC method. J. Res. Pharm. 2025;23(2):170-6.