Stability of hydroxyprogesterone caproate alone and in a compounded pharmaceutical product.
Purpose. The chemical stability of hydroxyprogesterone caproate in powder form and in a pharmaceutical formulation under different experimental conditions was evaluated. Methods. Pure hydroxyprogesterone caproate was subjected to hydrolysis, photolysis, and thermal degradation. The content of hydrox...
| Publicado en: | American Journal of Health-System Pharmacy Vol. 71; no. 13; pp. 1120 - 1128 |
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| Autores principales: | , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
7/1/2014
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103971718&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103971718 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10792082 1X3 jtl: American Journal of Health-System Pharmacy issn: 10792082 maglogo: N pubinfo: dt: 7/1/2014 vid: 71 iid: 13 pid: 622 pub: Oxford University Press / USA artinfo: ui: 103971718 96956768 10.2146/ajhp130466 NLM24939502 103971718 ppf: 1120 ppct: 8 formats: fmt: @attributes: type: P tig: atl: Stability of hydroxyprogesterone caproate alone and in a compounded pharmaceutical product. aug: au: Yang Zhao Bettinger, Joseph Caritis, Steve Venkataramanan, Raman affil: Research Associate, Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA sug: subj: Progesterone Drug Stability Drug Compounding Chemistry, Pharmaceutical Drug Contamination Parametric Statistics Sensitivity and Specificity Linear Regression Descriptive Statistics Data Analysis Software Childbirth, Premature Drug Therapy Recurrence Drug Therapy ab: Purpose. The chemical stability of hydroxyprogesterone caproate in powder form and in a pharmaceutical formulation under different experimental conditions was evaluated. Methods. Pure hydroxyprogesterone caproate was subjected to hydrolysis, photolysis, and thermal degradation. The content of hydroxyprogesterone caproate in pharmaceutical products was evaluated after using two different sterilization methods and after exposure to light. Hydroxyprogesterone caproate and its degradation products were analyzed using a validated reverse-phase high-performance liquid chromatographic method. Variables examined included specificity, accuracy, precision, linearity, theoretical plate numbers, signal:noise ratio, resolution between any two peaks, and relative standard deviation of the peak response. Statistical analysis was performed with Stata software, version 11 (StataCorp, College Station, TX). Mean values and standard deviations were calculated. The level of significance was set at p < 0.05. Results. Components of hydroxyprogesterone caproate and organic impurities in pharmaceutical products were scanned with wide ultraviolet wavelength from 200 to 400 nm. In powder form, hydroxyprogesterone caproate was stable when exposed to high temperatures and light. Considerable degradation of hydroxyprogesterone caproate was observed in alkaline solution, with the major degradation product being hydroxyprogesterone. Much less degradation of hydroxyprogesterone caproate was observed in acidic conditions over 72 hours. The content of hydroxyprogesterone caproate in pharmaceutical products was not altered by the sterilization methods (filtration or heat sterilization) used and after exposure to light. Conclusion. Hydroxyprogesterone caproate in powder form and in a pharmaceutical formulation under different experimental conditions appeared to be fairly stable in the presence of strong acid, high temperatures, and light. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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