• Divyani Jitendra Salve
• Dr. Vivekanand Ankush Kashid
• Nachiket S Dighe

A stability indicating RP-HPLC method was developed and validated for analysis of levothyroxine in single and Dosage form. The separation was achieved by using Zorbax Eclipse plus C 18 (250-mm × 4.6-mm; 5-µm) High performance liquid chromatograph, with UV / PDA detector. As a stationary phase with mobile phase consisting methanol: water (Dilution scheme: 20mg 100.0 ml / 1.0 ml 10.0 ml) PH3.0. the flow rate 1.0 ml / minute and optimum wavelength for detection was 225nm. The developed method was validated for precision, accuracy, ruggedness, robustness, linearity and range. The developed method was validated showed good linearity and range50% to 150% for levothyroxine. The forced degradation studies were performed as per ICH guidelines under acidic, alkali, photolytic, thermolytic conditions. The developed RP-HPLC method was found to be linear over wider concentration range. Thus, the developed RP-HPLC method can be used for routine quantitative and qualitative analysis of levothyroxine in bulk and pharmaceutical formulations like tablets and validated as per ICH guidelines. Hence proposed method could be employed for stability studies on pharmaceutical preparations within pharmaceutical industry.

levothyroxine, HPLC, methanol, reverse phase chromatography, validation

"METHOD DEVELOPMENT AND VALIDATION OF PHARMACEUTICAL BULK DOSAGE FORM OF LEVOTHYROXINE BY RP-HPLC METHOD", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 12, page no.d587-d598, December-2024, Available :http://www.jetir.org/papers/JETIR2412372.pdf

"METHOD DEVELOPMENT AND VALIDATION OF PHARMACEUTICAL BULK DOSAGE FORM OF LEVOTHYROXINE BY RP-HPLC METHOD", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 12, page no. ppd587-d598, December-2024, Available at : http://www.jetir.org/papers/JETIR2412372.pdf