Volume: 1 Issue: 1
Year: 2025, Page: 23-29,
Received: July 22, 2024 Accepted: Feb. 7, 2025 Published: April 11, 2025
Combination Dosage Forms generally refers to pharmaceutical formulations which contains two or more active ingredients in a single dosage unit or formulation. These combination dosage forms serve several important purposes in health care and play a crucial role by improving treatment outcomes, enhancing patient adherence and optimizing therapeutic regimens for various medical conditions. In this present strategy a stability indicating assay method was developed and validated as per ICH Guidelines for the simultaneous quantitation of Letrozole and Ribociclib in commercially available pharmaceutical dosage forms. The proposed method is based on Isocratic elution using Octa Decyl Silane (ODS) C18 (250*4.6 mm, 5 μm) column with a flow rate of 0.9 ml/min. The linear ranges for Letrozole and Ribociclib were found to be in the range of 1.25 -6.25μg/ml and 100-500 μg/ml. During the process of validation the intra and Interday Precision % RSD value was found to be less than 2 and recovery was in the range of 98-102%. The method was successfully applied for routine quality control analysis of dosage forms
Keywords: Ribociclib, Letrozole, 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