1Assistant Professor, Department of Quality Assurance / Chemistry, Smt. S. M. Shah Pharmacy College, Ahmedabad, Gujarat, Gujarat Technological University (GTU), Ahmedabad, Gujarat, India. Email: srushtijoshi74733@gmail.com; ORCID: 0009-0001-2454-6169
2Principal, Department of Pharmaceutics, Smt. S. M. Shah Pharmacy College, Ahmedabad, Gujarat, Gujarat Technological University (GTU), Ahmedabad, Gujarat, India. Email: kdethalia@gmail.com; ORCID: 0000-0002-0232-0628
3Associate Professor, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat, India, Gujarat Technological University (GTU), Ahmedabad, Gujarat, India. Email: amarsirsharda@gmail.com; ORCID: 0009-0005-1409-1745
4Assistant Professor, Vidhyadeep College of Pharmacy, Surat, Vidhyadeep University, Surat. Email: neetudharu148@gmail.com; ORCID: 0000-0002-4642-2087
5Doctor of Pharmacy Scholar, Pharm.D, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat Technological University (GTU), Ahmedabad, Gujarat, India. Email: samarth150304@gmail.com; ORCID: 0009-0005-6262-4905
6Assistant Professor, Department: Quality Assurance, Shri B. M. Shah College of Pharmaceutical Education and Research, Modasa – 383315, Gujarat Technological University (GTU). Email: aseakushkiwala@gmail.com; ORCID: 0009-0000-0380-7342
Corresponding Author: Srushti Yogeshbhai Joshi, Assistant Professor, Department of Quality Assurance / Chemistry, Smt. S. M. Shah Pharmacy College, Gujarat Technological University (GTU), Ahmedabad, Gujarat, India. Email: srushtijoshi74733@gmail.com; ORCID: 0009-0001-2454-6169
Objective: The present study aimed to develop and validate a simple, accurate, precise, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method for quantitative estimation of Sunitinib malate in pharmaceutical dosage form in accordance with International Council for Harmonisation (ICH) guidelines.
Methods: Chromatographic separation was achieved using a Hypersil BDS C18 column (250 × 4.6 mm, 5 µm) under isocratic conditions. The mobile phase consisted of 0.05 M potassium dihydrogen phosphate buffer (pH 4.5) and methanol in the ratio of 45:55 v/v at a flow rate of 1.0 mL/min. Detection was carried out at 225 nm. Forced degradation studies were performed under acidic, alkaline, oxidative, thermal, and photolytic stress conditions to establish stability-indicating capability. The method was validated as per ICH Q2(R1) guidelines.
Results: The developed method exhibited excellent linearity over the concentration range of 10–30 µg/mL with a correlation coefficient (r²) greater than 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.0219 µg/mL and 0.0665 µg/mL respectively, indicating high sensitivity. Precision studies showed %RSD less than 2%. Degradation products were well resolved from the main drug peak with resolution greater than 2, confirming specificity and stability-indicating nature of the method.
Conclusion: The validated RP-HPLC method is simple, sensitive, robust, and suitable for routine quality control analysis and stability studies of Sunitinib malate in pharmaceutical formulations.
Keywords: RP-HPLC; Sunitinib malate; Stability-indicating method; Forced degradation; Method validation; ICH guidelines.
How to cite this article: Joshi SY, Detholia KK, Raval AM, Dharu NR, Rathod SR, Kushkiwala AM. Development and Validation of a Stability-Indicating RP-HPLC Method for Quantitative Estimation of Sunitinib Malate in Pharmaceutical Dosage Form. Int J Drug Deliv Technol. 2026;16(12s): 418-426. DOI: 10.25258/ijddt.16.12s.48
Source of support: Nil.
Conflict of interest: None