Development of an HPLC Method for the Determination of Levothyroxine Applied to Four Different Preparations
Abstract
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.
Full Text:
PDFReferences
IDREES T, et al. Liothyronine and Desiccated Thyroid Extract in the Treatment of Hypothyroidism. Thyroid, 2020, 30(10): 1399-1413.
TANGUAY M, et al. Pharmacokinetics And Comparative Bioavailability Of A Levothyroxine Sodium Oral Solution And Soft Capsule. Clinical Pharmacology in Drug Development, 2019, 8(4): 521-528.
KAMALI H, et al. Optimization And In Vitro Evaluation of Injectable Sustained-Release Of Levothyroxine Using PLGA-PEG-PLGA. Journal of Pharmaceutical Innovation, 2020, 1-11.
COLUCCI P, et al. A Review of the Pharmacokinetics of Levothyroxine for the Treatment of Hypothyroidism. European Endocrinology, 2013, 9(1): 40.
TAYLOR PN, et al. Global Epidemiology Of Hyperthyroidism And Hypothyroidism. Nature Reviews Endocrinology, 2018. 14(5): 301-316.
KUMAR H, et al. Prevalence of hypothyroidism in females with depressive disorder. Journal of Pakistan Psychiatric Society, 2016, 13(4).
PARIZI MPS, et al. Environmental Photochemical Fate and UVC Degradation of Sodium Levothyroxine in Aqueous Medium. Environmental Science and Pollution Research, 2019, 26(5): 4393-4403.
LAGAN J, et al. Torsades De Pointes Cardiac Arrest Associated With Severe Hypothyroidism. British Journal of Cardiology, 2014, 21: 79.
COLLIER J, et al. Development and Application of A Validated HPLC Method for the Analysis of Dissolution Samples of Levothyroxine Sodium Drug Products. Journal of Pharmaceutical and Biomedical Analysis, 2011, 54(3): 433-438.
YUE C, SCARSI C, and DUCHARME M. Pharmacokinetics and Potential Advantages of a New Oral Solution of Levothyroxine Vs. Other Available Dosage Forms. Arzneimittelforschung, 2012, 62(12): 631-636.
AMERICAN THYROID ASSOCIATION, ENDOCRINE SOCIETY, & AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS (2004). Joint statement on the US Food and Drug Administration's Decision Regarding Bioequivalence of Levothyroxine Sodium. Thyroid, 2004, 14(7): 486-486.
GARBER JR, et al. Clinical Practice Guidelines for Hypothyroidism in Adults: Cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association. Thyroid, 2012, 22(12): 1200-1235.
JONKLAAS J, et al. Guidelines For The Treatment Of Hypothyroidism: Prepared By The American Thyroid Association Task Force On Thyroid Hormone Replacement. Thyroid, 2014, 24(12): 1670-1751.
UDOVCIC M, et al. Hypothyroidism and the Heart. Methodist Debakey Cardiovascular Journal, 2017, 13(2): 55.
TAYLOR PN, et al. Weekly Intramuscular Injection Of Levothyroxine Following Myxoedema: A Practical Solution To An Old Crisis. Case Reports in Endocrinology, 2015, 2015: 169194.
RICHHEIMER SL, and AMER TM. Stability-Indicating Assay, Dissolution, and Content Uniformity of Sodium Levothyroxine in Tablets. Journal of Pharmaceutical Sciences, 1983, 72(11): 1349-1351.
RAPAKA RS, KNIGHT PW, and PRASAD VK. Reversed‐Phase High‐Performance Liquid Chromatographic Analysis of Liothyronine Sodium and Levothyroxine Sodium in Tablet Formulations: Preliminary Studies On Dissolution And Content Uniformity. Journal of Pharmaceutical Sciences, 1981, 70(2): 131-134.
RAPAKA RS, et al. A Simple HPLC Method For The Dissolution Studies on Levothyroxine Sodium Tablets. International Journal of Pharmaceutics, 1982, 12(4): 285-294.
SMITH DJ, BIESEMEYER M, and YACIW C. The Separation and Determination of Liothyronine and Levothyroxine in Tablets by Reversed-Phase High Performance Liquid Chromatography. Journal of Chromatographic Science, 1981, 19(2): 72-78.
BROWER JF, TOLER DY, and REEPMEYER J C. Determination of Sodium Levothyroxine in Bulk, Tablet, and Injection Formulations by High-Performance Liquid Chromatography. Journal of Pharmaceutical Sciences, 1984, 73(9): 1315-1317.
GARNICK R, et al. High-Performance Liquid Chromatographic Assay For Sodium Levothyroxine In Tablet Formulations: Content Uniformity Applications. Journal of Pharmaceutical Sciences, 1984, 73(1): 75-77.
SAMANIDOU V, GIKA H, and PAPADOYANNIS I. Rapid HPLC Analysis of Thyroid Gland Hormones Tri-Iodothyronine (T3) and Thyroxine (T4) in Human Biological Fluids after SPE. Journal of Liquid Chromatography & Related Technologies, 2000, 23(5): 681-692.
KANNAMKUMARATH SS, et al. Determination of Levothyroxine and its Degradation Products in Pharmaceutical Tablets by HPLC-UV-ICP-MS. Journal of Analytical Atomic Spectrometry, 2004, 19(1): 107-113.
STEWART SA, et al. HPLC Method for Levothyroxine Quantification in Long-Acting Drug Delivery Systems. Validation and Evaluation of Bovine Serum Albumin as Levothyroxine Stabilizer. Journal of Pharmaceutical And Biomedical Analysis, 2021, 203: 114182.
GUPTA V, et al. Development and Validation of HPLC Method-A Review. International Research Journal of Pharmaceutical and Applied Sciences, 2012, 2(4): 17-25.
KAZAKEVICH YV, and LOBRUTTO R. HPLC for Pharmaceutical Scientists. 2007: John Wiley & Sons.
AHUJA S, and RASMUSSEN H. HPLS Method Development for Pharmaceuticals, Vol. 8 Book series: Separation Science and Technology. 2007, Elsevier, New York.
SABIR AM, MOLOY M, and BHASIN PS. HPLC Method Development and Validation: A Review. International Research Journal of Pharmacy, 2013, 4(4): 39-46.
RAO BV, et al. Review on Stability Indicating HPLC Method Development. World Journal of Pharmacy and Pharmaceutical Sciences, 2015, 4(8): 405-423.
EUROPEAN AGENCY FOR EVALUATION OF MEDICINAL PRODUCTS. ICH TOPIC Q2B: Validation of Analytical Procedures: Methodology. 1996, CPMP/ICH/281/95.
MEHTA AC. Quality Management in Drug Analysis. Analyst, 1997, 1B22(7): 83R-88R.
SHARIPOV A, et al. Development of an Improved Method for the Determination of Iodine/Β-Cyclodextrin by Means of HPLC-UV: Validation and the Thyroid-Stimulating Activity Revealed by in Vivo Studies. Pharmaceutics, 2021, 13(7): 955.
KAUR N, and SURYANARAYANAN R. Investigating the Influence of Excipients on the Stability of Levothyroxine Sodium Pentahydrate. Molecular Pharmaceutics, 2021, 18(7): 2683-2693.
Refbacks
- There are currently no refbacks.
