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Abstract
The formulation of skin patch may alleviate pain and inflammation effectively,and eliminate the side effects.The mobile phases used for the analysis of diclofenac sodium water-based medical patch were prepared with mixing equal volumes of 0.005 M Phosphoric acid and 0.005 M monobasic sodium ohosphate .The 0.005 M NaH2PO4 and 0.005M Na2HPO4 buffer solution adjusted to pH 2.5 by 1% phosophoric Acid solution in Phosphates buffer solution and methanol which ratio was 20 to 80. Chromatogrphic determination was performed with a HPLC system equipped with ODS Hypersil 250 × 4.6 mm (5 μm) column. The analytical conditions were UV-Vis absorption set at 280 nm, flow rate set at 1.0 mL/min and an injection of 10 μL. In the result of validation experiments, the linear regression coefficient (R2) of diclofenac sodium was 0.9998, the relative standard deviation (RSD) was between 0.17% and 1.62%, the average recovery was 94%~99.7% .
The high-performance liquid chromatography (HPLC) was used to analyze the content of diclofenac sodium of self-made water-based medical patch during a period of time and in the different temperature conditions in order to probe into the stability of formulation. The self-made diclofenac sodium water-based medical patch was placed in the room temperature condition (25±2°C / 60±5%RH) and the accelerated condition (40±2°C / 75±5%RH) for six-month stability tests, the content of dclofenac sodium declines6 % in the normal-temperature tests and declines 6.5 % in the accelerated tests.
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