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<p>Domperidone is a peripheral dopamine D2 receptor antagonist broadly used as an antiemetic and pro-kinetic. This study assessed the market landscape of commercially available domperidone products and performed comparative in-vitro quality control testing on four marketed tablet brands. A two-part approach was utilized. An online market survey catalogued branded and combination domperidone products available on Indian e- pharmacies. For laboratory assessment, a UV–visible spectrophotometric approach (λ max = 285&#xa0;nm) was developed and a calibration curve built utilizing standard dilutions (5–25&#xa0;µg/mL). Primary stock solutions were prepared from pure domperidone and tablet powder; secondary stocks and operation dilutions were prepared to obtain calibration and sample concentrations. Standard quality control tests; appearance, weight variation, hardness, friability, thickness/diameter, disintegration assay; were performed in triplicate per brand. The online survey revealed varied branded and combination formulations differing in strength, price and packaging. In-vitro evaluation of four selected brands (A–D) demonstrated adherence with pharmacopeial limits for physical parameters. Assay outcomes (% label assertion) were: A = 108%, B = 109%, C = 106% and D = 108%, indicating satisfactory strength with minor inter-brand variability. The evaluated domperidone tablets largely encountered standard quality specifications, though small assay variations highlight the weight of ongoing post-marketing monitoring and steady and regular production quality control to ensure therapeutic dependability.</p>

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Market Landscape and In-vitro Assessment of Commercially Available Domperidone Products

  • 期刊论文

  • 发表日期：

    2026年3月31日

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  • Himanshu Saini,
  • Hitesh Kumar,
  • Anushka Chopra,
  • Navneet Sharma,
  • Manish Dhall

摘要

Domperidone is a peripheral dopamine D2 receptor antagonist broadly used as an antiemetic and pro-kinetic. This study assessed the market landscape of commercially available domperidone products and performed comparative in-vitro quality control testing on four marketed tablet brands. A two-part approach was utilized. An online market survey catalogued branded and combination domperidone products available on Indian e- pharmacies. For laboratory assessment, a UV–visible spectrophotometric approach (λ max = 285 nm) was developed and a calibration curve built utilizing standard dilutions (5–25 µg/mL). Primary stock solutions were prepared from pure domperidone and tablet powder; secondary stocks and operation dilutions were prepared to obtain calibration and sample concentrations. Standard quality control tests; appearance, weight variation, hardness, friability, thickness/diameter, disintegration assay; were performed in triplicate per brand. The online survey revealed varied branded and combination formulations differing in strength, price and packaging. In-vitro evaluation of four selected brands (A–D) demonstrated adherence with pharmacopeial limits for physical parameters. Assay outcomes (% label assertion) were: A = 108%, B = 109%, C = 106% and D = 108%, indicating satisfactory strength with minor inter-brand variability. The evaluated domperidone tablets largely encountered standard quality specifications, though small assay variations highlight the weight of ongoing post-marketing monitoring and steady and regular production quality control to ensure therapeutic dependability.