Volume : 11, Issue : 09, September – 2024
Title:
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF LEVOTHYROXINE AND LIOTHYRONINE IN API AND PHARMACEUTICAL FORMULATION BY USING RP-HPLC.
Authors :
Jaina Anusha, Koppu Udaya Bhanu Sri*, Dr.D. Venkata Ramana, Dr. Gadipally Sai Kiran.
Abstract :
A new, simple and accurate, precise RP-HPLC method was developed for simultaneous determination of Levothyroxine and Liothyronine in bulk and in combined pharmaceutical dosage form. The separation of Levothyroxine and Liothyronine was achieved within 8 minutes on an Agilent Zorbax (C18) (150mm x 4.6mm, 5µm) column using Methanol: Acetonitrile (25:75v/v) as the mobile phase. Detection was carried out using wavelength at 265nm. The method showed adequate sensitivity concerning linearity, accuracy and precision over the range 100-500μg/ml and 30-70μg/ml for Levothyroxine and Liothyronine, respectively. Careful validation proved advantages of high sensitivity, accuracy, precision, selectivity, robust and suitability for quality control laboratories. The developed method was robust as the %RSD was within the range and without effecting system suitability parameters. The proposed method is suitable for simultaneous determination of Levothyroxine and Liothyronine in bulk and pharmaceutical dosage form.
Keywords: Levothyroxine and Liothyronine, RP-HPLC, Validation, Precision, Robustness, ICH Guidelines.
Cite This Article:
Number of Downloads : 10
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