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VOL. 10, ISSUE 4 (2025)
Comprehensive review on analytical and In-Vitro evaluation strategies for Zolpidem Tartrate and Melatonin in combined dosage forms
Authors
Patel Dimpalben Harshadbhai, Joshi Pooja, Munshi Mahammed Tanzil M, Dr. Deepa Patel, Dr. Ghanshyam Patel
Abstract
Combination therapy using Zolpidem Tartrate
and Melatonin is an emerging strategy for managing insomnia and sleep
disorders. Reliable analytical and in-vitro evaluation methods are
essential for quality control, stability assessment, and regulatory
submissions. This comprehensive review summarizes official pharmacopoeial
procedures and non-official (peer-reviewed, patent, and research) analytical
methods reported between 2010 and 2025 for Zolpidem, Melatonin, and their
combined formulations. Key techniques discussed include RP-HPLC, UPLC,
LC–MS/MS, HPTLC, UV/visible spectrophotometry, and emerging green and QbD-based
approaches. Comparative tables summarize columns, mobile phases, detection
wavelengths, linearity ranges, and limits of detection. Method validation
requirements per ICH Q2(R1/R2) are reviewed, and forced-degradation and
dissolution testing strategies are compared. Finally, the review highlights
challenges—solubility, matrix effects, and hormone instability—and recommends
best practices for developing stability-indicating, regulatory-compliant
methods suitable for publication dossiers and routine QC.
Pages:57-59
How to cite this article:
Patel Dimpalben Harshadbhai, Joshi Pooja, Munshi Mahammed Tanzil M, Dr. Deepa Patel, Dr. Ghanshyam Patel "Comprehensive review on analytical and <i>In-Vitro</i> evaluation strategies for Zolpidem Tartrate and Melatonin in combined dosage forms". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 10, Issue 4, 2025, Pages 57-59
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