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Design and content determination of nimesulide injectable formulation
Lei Luo1, Wanfu Tao2, Nadia Bourkaib3
1College of pharmaceutical science, Southwest University, Chongqing, China.
Pakistan Journal of Pharmaceutical Sciences
|July 6, 2015
Summary
This study developed an optimal injectable Nimesulide formulation and a validated high-performance liquid chromatography (HPLC) method for its content determination. The formulation is suitable for industrial production and quality control.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with limited injectable formulations.
- Development of stable and effective injectable dosage forms is crucial for therapeutic applications.
Purpose of the Study:
- To formulate an optimal injectable solution of Nimesulide.
- To establish and validate a high-performance liquid chromatography (HPLC) method for Nimesulide content determination.
- To gather data for regulatory registration of a new Nimesulide formulation.
Main Methods:
- Formulation development using single factor and orthogonal tests.
- Evaluation of formulation parameters including clarity, stability, pH, content, and related substances.
- Quantitative analysis of Nimesulide content using HPLC with UV detection.
Main Results:
- The optimal injectable formulation comprised 4% Nimesulide, 4% ethanolamine, 0.1% L-cysteine, 0.01% EDTA-2Na, lactic acid, and water for injection.
- The developed HPLC method demonstrated high sensitivity with a detection limit of 20-80 μg/mL.
- The method achieved excellent linearity (correlation coefficient 0.9995) and accuracy (average recovery 99.91%, RSD=0.06%).
Conclusions:
- The developed Nimesulide injectable formulation is suitable for pharmaceutical use.
- The established HPLC method is simple, sensitive, and accurate for Nimesulide content determination.
- The formulation and analytical method are appropriate for industrial production and quality control.
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