Development of an HPLC Method for the Determination of Levothyroxine Applied to Four Different Preparations
HPLC is an important research tool that can identify, extract and measure the substance, its numerous components and drug-related additives that may occur during either the manufacture or storage of the medication. Understanding the chemistry of the drug ingredient is required for this, which makes it easier to create analytical methods. To find the most effective way to conduct the procedure, many chromatographic parameters were investigated and tested. It is essential to identify a suitable mobile phase, column, column temperature, wavelength, and gradient to achieve the desired suitability and durability of the medicine in addition to its degradants and contaminants. This study aims to develop simply and rapidly the HPLC method for the determination of levothyroxine and its different brands. Levothyroxine is the drug of choice for hypothyroidism. In this study, a high liquid chromatography method was developed for the quantification of different brands of levothyroxine. The chromatographic study was analyzed at an ambient temperature of 28°C with isocratic elution. The mobile phase of the chromatograph was water and methanol Me OH (45:55) (1:1V/V) or 0.01 M phosphate buffer, the solution with adjusted pH=3. The flow rate of the pump was set at 1.5ml/min, the volume of the solution was 20 ml injected into the HPLC column, and the wavelength at 225 nm. The accuracy (99.9% recovery), precision (99.9 to 100% recovery), linearity (³ 0.99), and retention time (16.8 min) were observed for all brands of levothyroxine. In this study, we have evaluated the HPLC method for the quantification of levothyroxine and its different brands. Levothyroxine is considered as a controversial drug throughout the globe. In the recent past, we have found no study that proved clinical and biological interchangeability between levothyroxine brands. Our study is its self-unique in its case. There is no such publication proving that generic drugs are equivalent.
Keywords: levothyroxine, HPLC, analysis, different brands.
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