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Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation

Yıl 2023, Cilt: 27 Sayı: 6, 2522 - 2529, 28.06.2025

Prathamesh Shirole Dhanashree Sanap Kisan Jadhav

Öz

The current study describes a Q- Absorption Ratio spectrophotometric method development and validation for the simultaneous determination of esomeprazole magnesium and ondansetron hydrochloride. The concentration of the drugs was determined by using the ratio of absorbance at the iso-absorptive point (λ1 = 275 nm) and the λmax of esomeprazole magnesium (λ2 = 302 nm). This method is linear for both drugs in the range of 5–25 μg/mL at λ1 (R2 = 0.999) and at λ2 (R2 = 0.9998) for ondansetron hydrochloride, and esomeprazole magnesium found at λ1 (R2 = 0.9995) and λ2 (R2 = 0.9997). According to ICH recommendations Q2(R1), statistical analysis and recovery studies have been used to validate the analysis findings. The % Recovery was 97.78% – 100.81 % of ondansetron and 100.33% – 102.03 % of esomeprazole by the standard addition method. The method was found to be precise as the % relative standard deviation was less than 2.00 in interday and intraday precision for ondansetron and esomeprazole. The results of the current study indicated that the developed method is simple, linear, precise, accurate, and sensitive, hence may be used for quality control purposes.

Anahtar Kelimeler

Ondansetron hydrochloride esomeprazole UV-spectrophotometer validation accuracy precision

Kaynakça

  • [1] Kalaichelvi R, Madhava RB, Manikanta S, Gopinath G, Usha M, Venkata RD, Srinivasa RD, Jayachandran E. UV Spectrophotometric method for determination of Ondansetron hydrochloride in pure and its formulation. Int J Pharm Pharm Sci. 2012; 4(4): 151–152.
  • [2] Pranitha G, Venkateshwarlu G. Quantitative determination of few commercial drugs by using NBS and rhodamine-B couple: A spectrophotometric study. J Pharm Sci Res. 2016; 8(6): 390–394.
  • [3] United States of Pharmacopoeia, published by Secretary, Ministry of Health and Family Welfare. Volume II, Page no 4066.
  • [4] Jhansi K, Chiranjeevi P, Prasada RK, Srinivasa RY, Deepthi R. A validated UV spectrophotometric method for the estimation of esomeprazole magnesium trihydrate in bulk and commercial dosage form. J Global Trends Pharm Sci. 2020; 11(4): 8754–8760.
  • [5] Kumar PR, Shyale S, Gouda M, Kumar SMS. Physico-chemical characterization, UV spectrophotometric method development and validation studies of esomeprazole magnesium trihydrate. J Chem Pharm Res. 2010; 2(3): 484–490.
  • [6] Liu J, Stewart JT. High-performance liquid chromatographic analysis of ondansetron enantiomers in human serum using a reversed-phase cellulose-based chiral stationary phase and solid-phase extraction. J Chromatogr B. 1997; 694: 179–184. https://doi.org/10.1016/S0378-4347(97)00112-6
  • [7] Rajan N, Basha KA. HPLC method development for determination of glyoxal content in ondansetron HCl drug substances by derivatization with 2,4-DNPH. J Liq Chromatogr Relat Technol. 2014; 37(19): 2800–2808. https://doi.org/10.1080/10826076.2013.873871
  • [8] Mujtaba A, Kohli K, Ali J, Baboota S. Development of HPTLC method for the estimation of ondansetron hydrochloride in bulk drug and sublingual tablets. Drug Test Anal. 2011. https://doi.org/10.1002/dta.311
  • [9] Moreira RF, Salvadori MC, Azevedo CP, Silva DO, Borges DC, Moreno RA, Sverdloff CE, Borges NC. Development and validation of a rapid and sensitive LC-ESI-MS/MS method for ondansetron quantification in human plasma and its application in comparative bioavailability study. Biomed Chromatogr. 2010; 24: 1220–1227. https://doi.org/10.1002/bmc.1431
  • [10] Gayatri SN, Biju VMN, Starvin AM. Determination of ondansetron by spectrofluorimetry: application to forced degradation study, pharmaceuticals and human plasma. J Fluoresc. 2019; 29(1): 203–209. https://doi.org/10.1007/s10895-018-2329-x
  • [11] Badhan PB, Sonawane SS, Shelke AV, Jadhav AG. Spectrophotometric method development and validation of RP-HPLC method for determination of granisetron hydrochloride in bulk and injections. Int J Pharm Sci Res. 2021; 12(2): 1184–1189. https://doi.org/10.13040/IJPSR.0975-8232.12(2).1184-89
  • [12] Raposo F, Ibelli-Bianco C. Performance parameters for analytical method validation: Controversies and discrepancies among numerous guidelines. TrAC Trends Anal Chem. 2020; 129. https://doi.org/10.1016/j.trac.2020.115913
  • [13] Nayak S, Sarangi RR, Panda SK, Dash AK, Rath SK, Rath S. UV-spectrophotometric method for simultaneous estimation of paracetamol and ondansetron in bulk and their formulation. Int J Biol Pharm Res. 2011; 2(2): 45–49.
  • [14] Jain S, Maheshwari RK, Nema RK, Singhvi I. Development and validation of simple UV-spectrophotometric method of quantization of ondansetron hydrochloride in solid dosage formulations using hydrotropic solubilization technique. Int J Pharm Sci Drug Res. 2017; 9(5): 252–255. https://doi.org/10.25004/IJPSDR.2017.090509
  • [15] Savale SK. UV spectrophotometric method development and validation for quantitative estimation of ondansetron HCl. Asian J Res Chem Pharm Sci. 2017; 5(2): 83–86.
  • [16] Mundhey DA, Sapkal NP, Daud AS. Simultaneous quantification of buprenorphine HCl and naloxone HCl by Vierordt’s method. Int J Pharm Pharm Sci. 2016; 8(1): 101–107.

Yıl 2023, Cilt: 27 Sayı: 6, 2522 - 2529, 28.06.2025

Prathamesh Shirole Dhanashree Sanap Kisan Jadhav

Öz

Kaynakça

  • [1] Kalaichelvi R, Madhava RB, Manikanta S, Gopinath G, Usha M, Venkata RD, Srinivasa RD, Jayachandran E. UV Spectrophotometric method for determination of Ondansetron hydrochloride in pure and its formulation. Int J Pharm Pharm Sci. 2012; 4(4): 151–152.
  • [2] Pranitha G, Venkateshwarlu G. Quantitative determination of few commercial drugs by using NBS and rhodamine-B couple: A spectrophotometric study. J Pharm Sci Res. 2016; 8(6): 390–394.
  • [3] United States of Pharmacopoeia, published by Secretary, Ministry of Health and Family Welfare. Volume II, Page no 4066.
  • [4] Jhansi K, Chiranjeevi P, Prasada RK, Srinivasa RY, Deepthi R. A validated UV spectrophotometric method for the estimation of esomeprazole magnesium trihydrate in bulk and commercial dosage form. J Global Trends Pharm Sci. 2020; 11(4): 8754–8760.
  • [5] Kumar PR, Shyale S, Gouda M, Kumar SMS. Physico-chemical characterization, UV spectrophotometric method development and validation studies of esomeprazole magnesium trihydrate. J Chem Pharm Res. 2010; 2(3): 484–490.
  • [6] Liu J, Stewart JT. High-performance liquid chromatographic analysis of ondansetron enantiomers in human serum using a reversed-phase cellulose-based chiral stationary phase and solid-phase extraction. J Chromatogr B. 1997; 694: 179–184. https://doi.org/10.1016/S0378-4347(97)00112-6
  • [7] Rajan N, Basha KA. HPLC method development for determination of glyoxal content in ondansetron HCl drug substances by derivatization with 2,4-DNPH. J Liq Chromatogr Relat Technol. 2014; 37(19): 2800–2808. https://doi.org/10.1080/10826076.2013.873871
  • [8] Mujtaba A, Kohli K, Ali J, Baboota S. Development of HPTLC method for the estimation of ondansetron hydrochloride in bulk drug and sublingual tablets. Drug Test Anal. 2011. https://doi.org/10.1002/dta.311
  • [9] Moreira RF, Salvadori MC, Azevedo CP, Silva DO, Borges DC, Moreno RA, Sverdloff CE, Borges NC. Development and validation of a rapid and sensitive LC-ESI-MS/MS method for ondansetron quantification in human plasma and its application in comparative bioavailability study. Biomed Chromatogr. 2010; 24: 1220–1227. https://doi.org/10.1002/bmc.1431
  • [10] Gayatri SN, Biju VMN, Starvin AM. Determination of ondansetron by spectrofluorimetry: application to forced degradation study, pharmaceuticals and human plasma. J Fluoresc. 2019; 29(1): 203–209. https://doi.org/10.1007/s10895-018-2329-x
  • [11] Badhan PB, Sonawane SS, Shelke AV, Jadhav AG. Spectrophotometric method development and validation of RP-HPLC method for determination of granisetron hydrochloride in bulk and injections. Int J Pharm Sci Res. 2021; 12(2): 1184–1189. https://doi.org/10.13040/IJPSR.0975-8232.12(2).1184-89
  • [12] Raposo F, Ibelli-Bianco C. Performance parameters for analytical method validation: Controversies and discrepancies among numerous guidelines. TrAC Trends Anal Chem. 2020; 129. https://doi.org/10.1016/j.trac.2020.115913
  • [13] Nayak S, Sarangi RR, Panda SK, Dash AK, Rath SK, Rath S. UV-spectrophotometric method for simultaneous estimation of paracetamol and ondansetron in bulk and their formulation. Int J Biol Pharm Res. 2011; 2(2): 45–49.
  • [14] Jain S, Maheshwari RK, Nema RK, Singhvi I. Development and validation of simple UV-spectrophotometric method of quantization of ondansetron hydrochloride in solid dosage formulations using hydrotropic solubilization technique. Int J Pharm Sci Drug Res. 2017; 9(5): 252–255. https://doi.org/10.25004/IJPSDR.2017.090509
  • [15] Savale SK. UV spectrophotometric method development and validation for quantitative estimation of ondansetron HCl. Asian J Res Chem Pharm Sci. 2017; 5(2): 83–86.
  • [16] Mundhey DA, Sapkal NP, Daud AS. Simultaneous quantification of buprenorphine HCl and naloxone HCl by Vierordt’s method. Int J Pharm Pharm Sci. 2016; 8(1): 101–107.
Toplam 16 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılık ve İlaç Bilimleri (Diğer)
Bölüm Articles
Yazarlar

Prathamesh Shirole 0009-0007-1474-1175

Dhanashree Sanap 0000-0002-4794-7598

Kisan Jadhav 0000-0001-7563-3935

Yayımlanma Tarihi 28 Haziran 2025
Yayımlandığı Sayı Yıl 2023 Cilt: 27 Sayı: 6

Kaynak Göster

APA Shirole, P., Sanap, D., & Jadhav, K. (2025). Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation. Journal of Research in Pharmacy, 27(6), 2522-2529.
AMA Shirole P, Sanap D, Jadhav K. Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation. J. Res. Pharm. Temmuz 2025;27(6):2522-2529.
Chicago Shirole, Prathamesh, Dhanashree Sanap, ve Kisan Jadhav. “Development and Validation of Q-Absorbance Ratio Spectrophotometric Method for Simultaneous Estimation of Ondansetron HCl and Esomeprazole Magnesium in Bulk and Formulation”. Journal of Research in Pharmacy 27, sy. 6 (Temmuz 2025): 2522-29.
EndNote Shirole P, Sanap D, Jadhav K (01 Temmuz 2025) Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation. Journal of Research in Pharmacy 27 6 2522–2529.
IEEE P. Shirole, D. Sanap, ve K. Jadhav, “Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation”, J. Res. Pharm., c. 27, sy. 6, ss. 2522–2529, 2025.
ISNAD Shirole, Prathamesh vd. “Development and Validation of Q-Absorbance Ratio Spectrophotometric Method for Simultaneous Estimation of Ondansetron HCl and Esomeprazole Magnesium in Bulk and Formulation”. Journal of Research in Pharmacy 27/6 (Temmuz 2025), 2522-2529.
JAMA Shirole P, Sanap D, Jadhav K. Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation. J. Res. Pharm. 2025;27:2522–2529.
MLA Shirole, Prathamesh vd. “Development and Validation of Q-Absorbance Ratio Spectrophotometric Method for Simultaneous Estimation of Ondansetron HCl and Esomeprazole Magnesium in Bulk and Formulation”. Journal of Research in Pharmacy, c. 27, sy. 6, 2025, ss. 2522-9.
Vancouver Shirole P, Sanap D, Jadhav K. Development and validation of Q-absorbance ratio spectrophotometric method for simultaneous estimation of ondansetron HCl and esomeprazole magnesium in bulk and formulation. J. Res. Pharm. 2025;27(6):2522-9.