International Journal of Drug Delivery Technology
Volume 15, Issue 2

Analytical Strategies for Stability-Indicating Method Development: Challenges and Advances in Fixed-Dose Combination Formulations 

Neelakshi Tendulkar, Mohammad Asif

Department of Chemistry, Maulana Azad College, Affiliated to Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar (Aurangabad), Maharashtra, India 

Received: 27th Jan, 2025; Revised: 12th Apr, 2025; Accepted: 21st Apr, 2025; Available Online: 25th Jun, 2025 

ABSTRACT

Stability-indicating methods (SIMs) in the pharmaceutical industry are critical to guaranteeing product safety, efficacy, and compliance with regulatory requirements, especially for fixed-dose combination (FDC) formulations. The review addresses both advancements and challenges in SIMs by confronting the tremendous complexities posed by the presence of multiple active pharmaceutical ingredients (API) and their degradation pathways. The review surveys some works in which degradation products were investigated using traditional and novel methods, from HPLC, UHPLC, and HPTLC to spectroscopic techniques, on to the hyphenated techniques of LC-MS and GC-MS. The concepts of forced degradation and regulatory input found great emphasis along with advances such as AI-driven optimization, green chemistry, and real-time stability monitoring. Directions for future studies focus on implementing automation, environmentally-friendly methods, and hybrid techniques in a way that maximizes efficiency and viability and aligns with a rapidly changing regulatory environment. Therefore, this review underlines the need for robust, specific, and cost-effective SIMs to guarantee the long-term stability of FDC formulations.

Keywords: Stability-indicating methods, fixed-dose combination, forced degradation, analytical techniques, HPLC, UHPLC, hyphenated techniques

How to cite this article: Neelakshi Tendulkar, Mohammad Asif. Analytical Strategies for Stability-Indicating Method Development: Challenges and Advances in Fixed-Dose Combination Formulations. International Journal of Drug Delivery Technology. 2025;15(2):875-83. doi: 10.25258/ijddt.15.2.64

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