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HPTLC method validated for gentamicin sulphate in ointments

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Research area:medicine-clinical

What the study found

The study found that a stability-indicating high-performance thin-layer chromatography (HPTLC) method could identify and quantify gentamicin sulphate in an ointment formulation. The method separated gentamicin sulphate bands without interference from ointment excipients or degradation products.

Why the authors say this matters

The authors conclude that the method is simple and convenient for quality control of gentamicin ointments. They also note that it does not require sample pre-treatment, such as extraction from the ointment base.

What the researchers tested

The researchers developed and validated an HPTLC method using silica gel 60 F254 plates as the stationary phase and methanol:chloroform:ammonia solution (25%) in a 1:1:1 ratio as the mobile phase. They dissolved the ointment sample in chloroform:methanol (9:1) and validated the method according to International Council for Harmonisation guidelines.

What worked and what didn't

The method showed specificity by separating all three bands of gentamicin sulphate without interference from excipients or degradation products under photolytic, photolytic and oxidative, oxidative, acidic, and alkaline stress conditions. It was linear over 50–300 ng/band with R2 ≥ 0.99, and the reported limits of detection and quantification were 7.10 ng and 21.53 ng, respectively.

What to keep in mind

The available summary describes validation results for one ointment formulation and does not provide broader testing beyond that context. Other limitations are not described in the abstract.

Key points

  • The study validated a stability-indicating HPTLC method for gentamicin sulphate in an ointment formulation.
  • The method separated gentamicin sulphate from ointment excipients and degradation products under several stress conditions.
  • Linearity was reported across 50–300 ng/band with R2 ≥ 0.99.
  • The reported limits were 7.10 ng for detection and 21.53 ng for quantification.
  • No sample pre-treatment or extraction from the ointment base was required.

Disclosure

Research title:
HPTLC method validated for gentamicin sulphate in ointments
Authors:
K. M. Yasif Kayes Sikdar, Md Khairul Islam, Edith K. Y. Tang, Tomislav Sostaric, Lee Yong Lim, Cornelia Locher
Institutions:
The University of Western Australia, The University of Western Australia, The University of Western Australia, The University of Western Australia, The University of Western Australia, The University of Western Australia
Publication date:
2026-03-09
DOI:
10.3390/app16052613
OpenAlex record:
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AI provenance: This post was generated by gpt-5.4-mini (OpenAI). The original authors did not write or review this post.

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