A validated and stability indicating HPLC method for analysis of diminazene aceturate and antipyrine combination in a ready injectable solution

M.N. Abualhasan, N. Batrawi, A.N. Zaid, D.G. Watson

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Diminazene aceturate and Antipyrine combination therapy is widely used in veterinary medicine. A simple reverse HPLC method for the analysis of samples of a ready injectable formulation containing a mixture of active ingredients and inactive excipients has been developed. The HPLC analysis was carried out using a reversed phase (RP)-C18 (250 mm×4.0 mm, 5 μm) column. The isocratic mobile phase consisted of a mixture of acetonitrile, methanol, phosphate buffer and hexane sulfonate; the flow rate was 0.6 mL/min and ultraviolet detection was at 291 nm. This method was validated in accordance with FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity and the system suitability results were within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method could be used for purity and degradation evaluation of these formulations.
LanguageEnglish
Pages300-304
Number of pages5
JournalDrug Research
Volume63
Issue number6
DOIs
Publication statusPublished - 1 Jun 2013

Fingerprint

Antipyrine
High Pressure Liquid Chromatography
Injections
Veterinary Medicine
Excipients
Hexanes
Methanol
Buffers
Phosphates
Guidelines
diminazene aceturate
Therapeutics

Keywords

  • HPLC method
  • analysis
  • ready injectable solution
  • diminazene aceturate
  • antipyrine combination

Cite this

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abstract = "Diminazene aceturate and Antipyrine combination therapy is widely used in veterinary medicine. A simple reverse HPLC method for the analysis of samples of a ready injectable formulation containing a mixture of active ingredients and inactive excipients has been developed. The HPLC analysis was carried out using a reversed phase (RP)-C18 (250 mm×4.0 mm, 5 μm) column. The isocratic mobile phase consisted of a mixture of acetonitrile, methanol, phosphate buffer and hexane sulfonate; the flow rate was 0.6 mL/min and ultraviolet detection was at 291 nm. This method was validated in accordance with FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity and the system suitability results were within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method could be used for purity and degradation evaluation of these formulations.",
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A validated and stability indicating HPLC method for analysis of diminazene aceturate and antipyrine combination in a ready injectable solution. / Abualhasan, M.N.; Batrawi, N.; Zaid, A.N.; Watson, D.G.

In: Drug Research, Vol. 63, No. 6, 01.06.2013, p. 300-304.

Research output: Contribution to journalArticle

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AU - Batrawi, N.

AU - Zaid, A.N.

AU - Watson, D.G.

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AB - Diminazene aceturate and Antipyrine combination therapy is widely used in veterinary medicine. A simple reverse HPLC method for the analysis of samples of a ready injectable formulation containing a mixture of active ingredients and inactive excipients has been developed. The HPLC analysis was carried out using a reversed phase (RP)-C18 (250 mm×4.0 mm, 5 μm) column. The isocratic mobile phase consisted of a mixture of acetonitrile, methanol, phosphate buffer and hexane sulfonate; the flow rate was 0.6 mL/min and ultraviolet detection was at 291 nm. This method was validated in accordance with FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity and the system suitability results were within the acceptance criteria. A stability-indicating study was also carried out and indicated that this method could be used for purity and degradation evaluation of these formulations.

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KW - analysis

KW - ready injectable solution

KW - diminazene aceturate

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