SEPARATION OF SOMATROPIN AND ITS DEGRADATION PRODUCTS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY USING A REVERSED-PHASE POLYMERIC COLUMN

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NAFISI VARCHEH N.; SHAFAATI A.R.; ZARGHI A.; ABOU FAZELI R.

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Journal Paper

Paper Information

Journal: Iranian Journal of Pharmaceutical Research Year:2004 | Volume:3 | Issue:4 Page(s): 209-213

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Information Journal Paper

Title

SEPARATION OF SOMATROPIN AND ITS DEGRADATION PRODUCTS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY USING A REVERSED-PHASE POLYMERIC COLUMN

Author(s)

NAFISI VARCHEH N. | SHAFAATI A.R. | ZARGHI A. | ABOU FAZELI R. | Issue Writer Certificate

Keywords

SOMATROPIN

DEGRADATION PRODUCTS

HPLC; GRADIENT

POLYMERIC COLUMN

Abstract

The accurate prediction of protein stability is one of the most challenging goals in protein formulation and delivery. In this study, a gradient RP-HPLC method is described for the separation of human growth hormone (hGH) variants as deamidated and oxidized forms. The methodology employed a polymiric poly (styrene-co-divinylbenzene) column and a 1mL/min flow rate of a linear gradient of 0.1% v/v TFA/acetonitrile and TFA/Water (pH=2.0) mixture as the mobile phase. The overall run time of this method was 12 min and the average retention times were about 8.7 min for the native SOMATROPIN, 7.2 min for the deamidated form and 1.6 and 5.3 min for oxidized variants. The method was also validated in terms of selectivity, linearity, intra- and inter-day variations.In conclusion the method was found to have the potential for being applied as an initial and rapid evaluation method for assessing the quality and quantity of hGH during downstream processing, formulation and storage.

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APA: Copy

NAFISI VARCHEH, N., SHAFAATI, A.R., ZARGHI, A., & ABOU FAZELI, R.. (2004). SEPARATION OF SOMATROPIN AND ITS DEGRADATION PRODUCTS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY USING A REVERSED-PHASE POLYMERIC COLUMN. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 3(4), 209-213. SID. https://sid.ir/paper/287510/en

Vancouver: Copy

NAFISI VARCHEH N., SHAFAATI A.R., ZARGHI A., ABOU FAZELI R.. SEPARATION OF SOMATROPIN AND ITS DEGRADATION PRODUCTS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY USING A REVERSED-PHASE POLYMERIC COLUMN. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2004;3(4):209-213. Available from: https://sid.ir/paper/287510/en

IEEE: Copy

N. NAFISI VARCHEH, A.R. SHAFAATI, A. ZARGHI, and R. ABOU FAZELI, “SEPARATION OF SOMATROPIN AND ITS DEGRADATION PRODUCTS BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY USING A REVERSED-PHASE POLYMERIC COLUMN,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 3, no. 4, pp. 209–213, 2004, [Online]. Available: https://sid.ir/paper/287510/en

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