Volume: 1 Issue: 1
Year: 2025, Page: 23-29,
Received: July 22, 2024 Accepted: Feb. 7, 2025 Published: April 11, 2025
Combination dosage forms are pharmaceutical preparations that include two or more active therapeutic agents within a single unit. These formulations are widely used in clinical practice because they help simplify treatment regimens, improve patient adherence, and enhance overall therapeutic effectiveness. In the present study, a stability-indicating assay method was developed and validated according to ICH guidelines for the simultaneous estimation of Letrozole and Ribociclib in combined pharmaceutical formulations. Chromatographic separation was performed using an ODS C18 column (250 × 4.6 mm, 5 μm) under isocratic conditions with a flow rate of 0.9 mL/min. The method demonstrated linearity for Letrozole across 1.25–6.25 μg/mL and for Ribociclib across 100–500 μg/mL. Validation results confirmed that both intraday and interday precision showed %RSD values below 2%, and accuracy studies yielded recoveries within 98–102%, meeting acceptable analytical standards. Thus, the developed method is precise, accurate, and reliable, making it suitable for routine quality control of these combination dosage forms.
Keywords: Ribociclib, Letrozole, Method Validation, Isocratic
Bao X, Wu J, Sanai N, Li J. 2019. Determination of total and unbound ribociclib in human plasma and brain tumor tissues using liquid chromatography coupled with tandem mass spectrometry. J Pharm Biomed Anal 166: 197–204.
Dange Y, Bhinge S, Salunkhe V. 2018. Optimization and validation of RP-HPLC method for simultaneous estimation of palbociclib and letrozole. Toxicol Mech Methods 28: 187–194.
Jarde T, Perrier S, Vasson MP, Caldefie-Chezet F. 2011. Molecular mechanisms of leptin and adiponectin in breast cancer. Eur J Cancer 47(1): 33–43.
Kala A, Patel YT, Davis A, Stewart CF. 2017. Development and validation of LC-MS/MS methods for the measurement of ribociclib, a CDK4/6 inhibitor, in mouse plasma and Ringer’s solution and its application to a cerebral microdialysis study. J Chromatogr B Analyt Technol Biomed Life Sci 1057: 110–117.
Kaplan C, Ünal S. 2018. A validated method without derivatization for the determination of letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation. Istanbul: Istanbul University Press 38–42.
Lee VCY, Ng EHY, Yeung WSB, Ho PC. 2011. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol 117(2 Pt 1): 317–323.
Mondal N, Pal TK, Ghosal SK. (2009). 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. 66:11-7.6.
Raymond EG, Grossman D, Weaver MA, Toti S, Winikoff B. (2014). Mortality of induced abortion, other outpatient surgical procedures and common activities in the United States. Contraception. 90(5):476-9.
Riggins RB, Bouton AH, Liu MC, Clarke R. (2005). Antiestrogens, aromatase inhibitors, and apoptosis in breast cancer. Vitam Horm. 71:201-37. PMID 16112269.
Sreelakshmi M, Sasidhar RL, Raviteja B. (2019). Simultaneous estimation of ribociclib and palbociclib in bulk samples by reverse phase high performance liquid chromatography. Int J Pharm Biol Sci. 9:413-21.
Tan RB, Guay AT, Hellstrom WJ. (2014). Clinical use of aromatase inhibitors in adult males. Sex Med Rev. 2(2):79-90.
© Vignan’s University, Guntur
V Pavan Kumar, S Jagadeesh, S Mahirah, V Amaravathi. A Stability Indicating Liquid Chromatographic Assay Method for the Simultaneous Determination of anti-cancer drugs in bulk and Pharmaceutical Dosage Forms. Vig J Biotech Phar. 2025;1(1):23-29