QBD APPROACH TO ANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION FOR ESTIMATION OF LENVATINIB IN BULK AND PHARMACEUTICAL FORMULATION

Authors

  • SACHIN A. BABAR Department of Chemistry, K. B. P. Mahavidyalaya Pandharpur, Punyashlok Ahilyadevi Holkar Solapur University, Pandharpur, India 413304
  • SUDHAKAR L. PADWAL Department of Chemistry, K. B. P. Mahavidyalaya Pandharpur, Punyashlok Ahilyadevi Holkar Solapur University, Pandharpur, India 413304

DOI:

https://doi.org/10.22159/ijap.2021v13i5.41786

Keywords:

Quality by design, Design expert 8, RP-HPLC, Lenvatinib

Abstract

Objective: The objective of this research was to develop a simple, very rapid, sensitive, accurate, precise reverse phase High-Performance Liquid Chromatography (RP-HPLC) technique for the estimation of Lenvatinib in bulk and its dosage form.

Methods: To perform this study, we employed a central composite design (CCD) to make method robust and effective to create chromatographic database. The factor screening studies were performed using 2-factor 10-runs. The factors were selected as the mobile phase ratio and buffer pH.

Results: The desirability value of the optimized model was found to be 0.869 and The optimized chromatographic condition was achieved on Enable C18 analytical column with 0.01M Ammonium acetate buffer pH 3.84: methanol (33.17:66.83 v/v) as the mobile phase and flow rate of 1 ml min-1 and detection wavelength was set to 240 nm. The retention time of Lenvatinib was found to be 5.122 min. Linearity was established for Lenvatinib in the range of 10-50 µg/ml with a correlation coefficient (r2=0.9995). The accuracy values were found to be in the range of 98–102%. Intraday precision and Interday precision were in prescribed (Less than 0.98% RSD). Robustness was found to be less than 1.22% RSD.

Conclusion: The proposed method was useful for best analysis of Lenvatinib in Bulk pharmaceutical dosage forms. Central Composite Design was an effective tool for the proposed RP-HPLC method.

Downloads

Download data is not yet available.

References

Patve RS, Shaikh AR, Inamdar N, Bhise K. Method development and validation of lenvatinib by HPLC and UV-spectroscopy. Indian Drugs 2018;55:39-7.

Prashanthi Y, Ahmed MA, Vijaya K, Riyazuddin. Method development and validation of lenvatinib drug by RP-HPLC in pharmaceutical drug dosage form, Indo. Am J Pharm Sci 2016;3:1078-85.

Panigrahy UP, Reddy AK. A novel validated RP-HPLC-DAD method for the estimation of lenvatinib mesylate in bulk and pharmaceutical dosage form. J Chem Pharm Res 2015;7:872-81.

Waghmare SA, Sumithra M. Full factorial experimental design for development and validation of RP-HPLC method for estimation of apixaban in bulk and pharmaceutical formulations. J Seybold Rep 2020;15:3428-42.

Waghmare SA, Kale PB, Desai RS, Takale S, Jadhav M, Bayas JP. Analytical method development and validation for determination of telmisartan in bulk and pharmaceutical formulation by QbD approach. IJAEMA 2020;12:1567-71.

Pukale AK, Giri SS, Waghmare SA. Qbd approach to UV-visible spectroscopic method development and validation for the estimation of ranolazine in bulk and pharmaceutical formulation. Eur J Biomed Pharm Sci 2018;5:740-5.

Waghmare SA, Kashid AM. Reverse phase-high performance liqui chromatography method development and validation for estimation of efavirenz by quality by design approach. J Drug Delivery Ther 2019;9:319-30.

Sanap A, Choudhary PS, Kale PB, Waghmare SA. Analytical method development and validation for estimation of oseltamivir phosphate in bulk and pharmaceutical formulation by QbD approach. IJAEMA 2020;12:463-70.

Giri SS, Pukale AK, Waghmare SA. Spectroscopic method development and validation for estimation of apixaban in bulk and pharmaceutical formulation by QbD approach. Eur J Biomed Pharm Sci 2018;5:637-42.

Rajkotwala S, Shaikh SS, Dedania ZR, Dedania RR, Vijendraswamy SM. QbD Approach to analytical method development and validation of piracetam by HPLC. World J Pharm Pharm Sci 2016;5:1771-84.

Garg NK, Sharma G, Singh B, Nirbhavane P, Katare OP. Quality by design (QbD)-based development and optimization of a simple, robust RP-HPLC method for the estimation of methotrexate. J Liq Chromatogr Relat Technol 2015;38:1629-37.

Mandlik SK, Agrawal PP, Dandgavhal HP. Implementation of quality by design (Qbd) approach in formulation and development of ritonavir pellets using extrusion spheronization method. Int J Appl Pharm 2020;12:139-46.

Srujani CH, Annpurna P, Nataraj KS, Pawar KM. Analytical quality by design approach in RP-HPLC method development and validation for the estimation of duvelisib. Asian J Pharm Clin Res 2021;14:99-108.

Published

07-09-2021

How to Cite

BABAR, S. A., & L. PADWAL, S. (2021). QBD APPROACH TO ANALYTICAL METHOD DEVELOPMENT AND ITS VALIDATION FOR ESTIMATION OF LENVATINIB IN BULK AND PHARMACEUTICAL FORMULATION. International Journal of Applied Pharmaceutics, 13(5), 183–188. https://doi.org/10.22159/ijap.2021v13i5.41786

Issue

Section

Original Article(s)