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ABSTRACT:

A New specific, economic and selective, accurate, precise and robust Reverse Phase High Performance Liquid Chromatography was developed for the quantification of Semaglutide in pharmaceutical substance and product. Chromatographic separation was achieved by C18 column (Azilent C18 150x 4.6, 5pm) is used as stationary phase and 0.01N Potassium dihyrogen ortho phosphate: Acetonitrile (50:50) used as a mobile phase at a flow rate of 1.0 mL/min and monitored at 230nm. The run time was 5min. The retention time of Semaglutide was found to be 2.222min. To fulfil the International Conference on Harmonisation requirements developed method was validated. Validation parameters include system suitability, specificity, linearity, accuracy, precision, intermediate precision and robustness. Calibration curve was linear over the concentration range of 7-42 pg/ml. From regression analysis relative correlation coefficient (R2) value was found to be 0.999. Accuracy and precision results were within the limits. LOD and LOQ were found to be 0.007 pg/ml and 0.022 pg/ml respectively. Semaglutide was subjected to the stress conditions like acidic, basic, oxidative, photolytic and thermal conditions. In acidic, alkaline and peroxide stress conditions. In acidic, alakaline and oxidative conditions degradant peaks were observed but there is no interference with semaglutide peak in all accelerated conditions, hence proving the stability indicating and specific nature of method. Assay result was found to be 99.99% W/W, thus it is proving that the method can also be applied for the estimation of Semaglutide in pharmaceutical drug product.

KEYWORDS: RP-HPLC, Semaglutide, Stability indicating, Analytical method development, Analytical method validation, pharmaceutical drug product.

INTRODUCTION:1-8

Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes. This drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes.1 IUPAC name of Semaglutide is 17-{[(1R)-3-[(2-{2-[({2-[2-({[(5S)-5[(2S)-2-[(2S)-2-[(2S)-2-{2[(2S)-2-[(2S)-2-[(2S)-2[(2S)-2[(2S)-2-[(2S)-2[(2S)-2-[(2S)-2-[(2S,3R)-2[(2S)-2[(2S,3R)-2-{2-[(2S)-2-{2-[(2S)-2-amino-3(1H-imidazol-4-yl) propanamido]-2methylpropanamido} -4-carboxybutanamido] acetamido} -3-hydroxybutanamido] -3phenylpropanamido] -3-hydroxy butanamido] -3hydroxypropanamido] -3 -carboxypropanamido] -3- methylbutanamido] -3 -hydroxypropanamido] -3hydroxypropanamido] -3 - (4-hydroxyphenyl) propanamido]-4- methylpentanamido]-4-carboxybutanamido] acetamido} -4-carbamoylbutanamido] propanamido] propanamido]-5-{[(1S)-1-{[(1S)-1-{[(1S,2S)-1-{[(1S)-1-{[(1S)-1-{[(1S)-1-{[(1S)-1-{[(1S)-4-carbamimidamido-1-[({[(1S)-4-carbamimidamido-1-[(carboxymethyl) carbamoyl]butyl] carbamoyl} methyl) carbamoyl]butyl] carbamoyl}-2-methylpropyl] carbamoyl}-3-methylbutyl] carbamoyl}-2-(1H-indol-3-yl)ethyl] carbamoyl}ethyl] carbamoyl}-2-methylbutyl] carbamoyl}-2-phenylethyl] carbamoyl}-3 carboxypropyl] carbamoyl} pentyl] carbamoyl} methoxy) ethoxy] ethyl} carbamoyl) methoxy] ethoxy}ethyl) carbamoyl]-1-carboxypropyl] carbamoyl} heptadecanoic acid. The molecular weight and chemical structures were 720.196g/mol and C187H291N45O59. Structure of Semaglutide shown in Fig No: 1

There is only one procedure is reported for quantification of...

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