Swaroop Rameshwarji LAHOTI, Sowmya PRIYADARSINI

RP-HPLC method development and validation for quantification of letrozole solid lipid nanoparticle

A sensitive, simple, rapid, stability-indicating reverse-phase high-pressure liquid chromatographic method was developed for the estimation of letrozole in solid lipid nanoparticles. The developed method was validated as per the International Council of Harmonization (ICH guideline) concerning system suitability, linearity, accuracy, precision, specificity, robustness, and range. The chromatographic separation was achieved on the Zorbax C18 column (250 x 4.6 mm ID; 5.0 μm particle size). Isocratic elution was performed using methanol: 0.1% orthophosphoric acid (60:40) at 0.7 mL/min flow rate. The detection was done using a UV-Vis detector at 240 nm. Linearity for the analytical method was observed at the concentration range of 10 to 50 μg/mL having a correlation coefficient of 0.999. The method was precise, accurate with a relative standard deviation (RSD) ≤ 2.0. The developed validated analytical method can be used as a quality control tool for the quantitative estimation of letrozole in a novel formulated solid lipid nanoparticle.

PDF

___

[1] O Neil MJ, The Merck Index: An enclyopedia of chemicals, drugs and biological, fourtheenth ed., Merck, Whitehouse Station, NJ, 2006.
[2] Maniyar M, Chakraborty A, Kokare C. Formulation and evaluation of letrozole-loaded spray-dried liposomes with PEs for topical application. J Liposome Res. 2020; 30(3): 274-284. [CrossRef]
[3] Torre LA, Islami F, Siegel RL, Ward EM, Jemal A. Global cancer in women: burden and trends. Cancer Epidemiol Biomark Prev. 2017; 26(4): 444-457. [CrossRef]
[4] Trunet PF, Bhatnagar AS, Chaudri HA, Hornberger U. Letrozole (CGS 20267), a new oral aromatase inhibitor for the treatment of advanced breast cancer in postmenopausal patients. Acta Oncol. 1996; 35(sup5): 15-18. [CrossRef]
[5] Miller WR, Larionov AA. Understanding the mechanisms of aromatase inhibitor resistance. Breast Cancer Res. 2012; 14(1): 1-11. [CrossRef]
[6] Johnson PE, Buzdar A. Are differences in the available aromatase inhibitors and inactivators significant?. Clin Cancer Res. 2001; 7(12 suppl): 4360s-4368s.
[7] Fabian CJ. The what, why, and how of aromatase inhibitors: hormonal agents for treatment and prevention of breast cancer. Int J Clin Pract. 2007; 61(12): 2051-2063. [CrossRef]
[8] Mahajan A, Rawal S, Bedi PM, Mahajan N, Sharma A. Aromatase inhibitors: A new hope for breast cancer patıents. IJPSR. 2010; 1(6): 27- 40.
[9] Yadav N, Khatak S, Sara UVS. Solid lipid nanoparticles-a review. Int J App Pharm. 2013; 5(2): 8-18.
[10] Panda SS, Ravi Kumar Bera VV, Sahu B. Integrated quality by design (QbD) and quality risk management (QRM) based liquid chromatographic method development and validation for estimation of capecitabine in pharmaceutical dosage form. Anal Chem Lett. 2018; 8(5): 665-676. [CrossRef]
[11] Prathyusa P, Sundarrajan R. A review on different analytical methods:Letrozole. Acta Sci Pharm Sci. 2020; 4(2): 85- 88. [CrossRef]
[12] Mondal N, Pal TK, Ghosal SK. Development and validation of RP-HPLC method to determine letrozole in different pharmaceutical formulations and its application to studies of drug release from nanoparticles. Acta Pol Pharm. 2009; 66 (1): 11-17.
[13] Kaplan C, Unal D. A validated method without derivatization for the determination of Letrozole by high-performance liquid chromatography-fluorimetric method for pharmaceutical preparation. Istanbul J Pharm. 2018; 48(2): 38-42. [CrossRef]
[14] Annapurna MM, Mohapatro C, Narendra A. Stability-indicating liquid chromatographic method for the determination of Letrozole in pharmaceutical formulations. J Pharm Anal. 2012; 2(4): 298-305. [CrossRef]
[15] Shrivastava A, Chakraborty AK, Rambhade SK, Patil UK. Development of validated RP-HPLC method for determination of letrozole in bulk and its pharmaceutical dosage forms. Pharm Sin. 2011; 2(2): 263-269.
[16] Validation of analytical procedures: text and methodology: Q2 (R1). https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf (assessed on 08 Jan 2022).
[17] Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal. 2014; 4(3): 159-165. [CrossRef]
[18] Sabir AM, Moloy M, Parminder B. HPLC method development and validation: A review. Int Res J Pharm. 2013; 4(4): 39-46. [CrossRef]
[19] Kumar SD, Kumar DRH. Importance of RP-HPLC in analytical method development: a review. IJPSR. 2012; 3(12): 4626-4633. [CrossRef]
[20] Reverse phase chromatography, principles and method, Amersham Pharmacia Biotech, 1999.
[21] Viana OD, Medeiros FP, Grangeiro Junior S, Albuquerque MM, Soares MF, Soares-Sobrinho JL, Alves LD, Rolim LA, Silva KE, Rolim-Neto PJ. Development and validation of a HPLC analytical assay method for efavirenz tablets: A medicine for HIV infections. Braz J Pharm Sci. 2011; 47(1): 97-102.
[22] Bakshi M, Singh S. Development of validated stability-indicating assay methods—critical review. J Pharm Biomed Anal. 2002; 28(6): 1011-1040. [CrossRef]
[23] Kaushal CK, Srivastava B. A process of method development: a chromatographic approach. J Chem Pharm Res. 2010; 2(2): 519-545.
[24] Ranganathan HP, Govindrajulu GE, Palaniyappan VE. Forced degradation study of letrozole—a validated stabilityindicating HPLC assay for bulk and tablet dosage form. J Pharm Biomed Anal. 2012; 4(2): 582-586.
[25] Zuvela P, Skoczylas M, JayLiu J, Ba̧czek T, Kaliszan R, Wong MW, Buszewski B. Column characterization and selection systems in reversed-phase high-performance liquid chromatography. Chem Rev. 2019; 119(6): 3674-3729. [CrossRef]
[26] Prasad H, Govindrajulu G, Palaniyappan V. Forced degradation study of letrozole a validated stability indicating HPLC assay for bulk and tablet dosage form. Int J Pharm Sci. 2012; 4(2): 582-586.
[27] Chan CC, Lee YC, Lam H, Zhang XM. Analytical method validation and instrument performance verification, First ed., Wiley- interscience, Newyork, 2004.
[28] Lavanya G, Sunil M, Eswarudu MM, Chinna Eswaraiah M, Harisudha K, Spandana BN. Analytical method validation: An updated review. Int J Pharm Sci Res. 2013; 4(4): 1280-1286. [CrossRef]
[29] Palleria S, Prabhakar B. Development and validation of Temozolomide solid lipid nanoparticle formulation by RPHPLC method. J Pharm Biomed Sci. 2015; 05(09): 745-749.
[30] Ahmad S, Mohammed Usman MR. Analytical method development and validation for the simultaneous estimation of emtricitabine and tenofovir by reversed phase high performance liquid chromatography in bulk and tablet dosage forms. Asian J Pharm Clin Res. 2017; 10(11): 59-64. [CrossRef]
[31] Managuli RS, Kumar L, Chonkar AD, Shirodkar RK, Lewis S, Koteshwara KB, Reddy MS, Mutalik S. Development and validation of a stability-indicating RP-HPLC method by a statistical optimization process for the quantification of asenapine maleate in lipidic nanoformulations. J Chromatogr Sci. 2016; 54(8): 1290-1300. [CrossRef
[32] Ramani VD, Jani GK, Sen AK, Sailor GU, Sutariya VB. Development and validation of RP-HPLC method for pitavastatin calcium in bulk and formulation using experimental design. J App Pharm Sci. 2019; 9(10): 75-83. [CrossRef]