Validation of HPLC method for quantitative determination of gefitinib in polymeric nanoformulation

K. S. Navya Sree, K. Girish Pai, Ruchi Verma, Padiyar Ananthakrishna, Lalit Kumar

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Gefitinib was determined quantitatively in a nanoformulation using the proposed HPLC method. Effective elution was achieved by using a stationary phase of HyperClone (Phenomenex®) C18 column (250 mm × 4.6 mm i.d., 5 µm, BDS 130 Å) and a mobile phase composed of acetonitrile and 40 mM ammonium formate buffer pH 2.5 (30: 70, %v/v) at a flow rate of 1.0 mL/min. The samples were measured at 248 nm using UV detector. The column temperature was kept at 25°C; the run time was 7 min; the injection volume was 20 µL. Gefitinib was separated within 4.476 min. The correlation coefficient for the obtained calibration curve was found to be 0.998. The method was validated according to ICH Q2 (R1) guidelines for linearity, sensitivity, robustness, accuracy and precision. The LOD and LOQ were found to be 37.852 and 114.702 ng/mL, respectively.

Original languageEnglish
Article numberA2604
Pages (from-to)159-163
Number of pages5
JournalPharmaceutical Chemistry Journal
Volume51
Issue number2
DOIs
Publication statusPublished - 2017

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formic acid
High Pressure Liquid Chromatography
Calibration
Buffers
Guidelines
Injections
Temperature
gefitinib
acetonitrile

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Drug Discovery

Cite this

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title = "Validation of HPLC method for quantitative determination of gefitinib in polymeric nanoformulation",
abstract = "Gefitinib was determined quantitatively in a nanoformulation using the proposed HPLC method. Effective elution was achieved by using a stationary phase of HyperClone (Phenomenex{\circledR}) C18 column (250 mm × 4.6 mm i.d., 5 µm, BDS 130 {\AA}) and a mobile phase composed of acetonitrile and 40 mM ammonium formate buffer pH 2.5 (30: 70, {\%}v/v) at a flow rate of 1.0 mL/min. The samples were measured at 248 nm using UV detector. The column temperature was kept at 25°C; the run time was 7 min; the injection volume was 20 µL. Gefitinib was separated within 4.476 min. The correlation coefficient for the obtained calibration curve was found to be 0.998. The method was validated according to ICH Q2 (R1) guidelines for linearity, sensitivity, robustness, accuracy and precision. The LOD and LOQ were found to be 37.852 and 114.702 ng/mL, respectively.",
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Validation of HPLC method for quantitative determination of gefitinib in polymeric nanoformulation. / Navya Sree, K. S.; Girish Pai, K.; Verma, Ruchi; Ananthakrishna, Padiyar; Kumar, Lalit.

In: Pharmaceutical Chemistry Journal, Vol. 51, No. 2, A2604, 2017, p. 159-163.

Research output: Contribution to journalArticle

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AU - Navya Sree, K. S.

AU - Girish Pai, K.

AU - Verma, Ruchi

AU - Ananthakrishna, Padiyar

AU - Kumar, Lalit

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