Analytical method development and validation of Erlotinib hydrochloride in bulk and pharmaceutical dosage form by RP-HPLC

  • Amjad Ali Mohammad Iqbal Oriental College of Pharmacy, Sanpada, Navi Mumbai 400705, M.S, India.
  • Mufassir Momin Department of Quality Assurance, Y. B. Chavan College of Pharmacy, Aurangabad 431003, M.S, India.
  • Sarfaraz Khan Department of Quality Assurance, Y. B. Chavan College of Pharmacy, Aurangabad 431003, M.S, India.
  • Firoz Khan Anjuman-I-Islam's Kalsekar Technical Campus, School of Pharmacy, New Panvel 410206, M.S, India.

Abstract

A simple, precise and accurate method for the estimation of Erlotinib in bulk and pharmaceutical dosage forms by reverse phase high performance liquid chromatography method was developed. A reverse phase Grace C18 column (250 cm · 4.6 mm · 5 μm) with mobile phase consisting of potassium dihydrogen orthophosphate, acetonitrile and methanol (50:30:20 V/V) having pH 4.0 which was adjusted by using orthophosphoric acid. The flow rate was 1 mL min-1 and the effluents were monitored at 247 nm. The retention time was found to be 5.83 min. The drug shows good linearity within the range of 10–60 μg mL-1. The inter-day and intra-day variation was found to be less the 2%. The mean recovery of drug from solution was 101.10%. The results of analysis have been validated according to ICH guideline requirements. The method can be applied for the estimation of Erlotinib in pharmaceutical dosage form.

Keywords: Erlotinib, Validation, Retention time, Acetonitrile, Accuracy, Precision

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References

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Published
30/09/2018
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Iqbal, A. A. M., Momin, M., Khan, S., & Khan, F. (2018). Analytical method development and validation of Erlotinib hydrochloride in bulk and pharmaceutical dosage form by RP-HPLC . Journal of Innovations in Applied Pharmaceutical Science (JIAPS), 3(3), 01-06. Retrieved from https://saap.org.in/journals/index.php/jiaps/article/view/195
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Research Article(S)