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| Souza,Mateus Araújo Castro e; Pereira,Carlos Eduardo de Oliveira; Nogueira,Fernando Henrique Andrade; Pianetti,Gerson Antônio. |
| ABSTRACT A stability indicating HPLC method to determine diltiazem hydrochloride (DTZ) in tablets and compounded capsules was developed and validated according to Brazilian and the International Conference on Harmonization (ICH) guidelines. The separation was carried out on a Purospher Star® C18 (150 x 4.6 mm i.d., 5 µm particle size, Merck Millipore) analytical column. The mobile phase consisted of a 0.05% (v/v) trifluoroacetic acid aqueous solution and a 0.05% trifluoroacetic acid methanolic solution (44:56, v/v). The flow rate was 1.0 mL.min-1 with a run time of 14 minutes. The detection of DTZ and degradation products (DP) was performed at 240 nm, using a diode array detector. The method proved to be linear, precise, accurate, selective, and robust,... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Diltiazem hydrochloride/compounded capsules; Diltiazem hydrochloride/tablets; High performance liquid chromatography /method validation; Stability indicating method. |
| Ano: 2017 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502017000300602 |
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| Nogueira,Fernando Henrique Andrade; Reis,Naialy Fernandes Araújo; Chellini,Paula Rocha; César,Isabela da Costa; Pianetti,Gerson Antônio. |
| The present study developed and validated an HPLC method for the simultaneous determination of artesunate (AS) and mefloquine hydrochloride (MQ) in fixed-dose combination tablets, according to ICH guidelines. The chromatographic separation was carried out on an XBridge C18 (250 x 4.6 mm i.d., 5 µm particle size, Waters) analytical column. The mobile phase included a 0.05 M monobasic potassium phosphate buffer (pH adjusted to 3.0 with phosphoric acid) and acetonitrile (50 + 50, v/v). The flow rate was 1.0 mL/min, and the run time was 13 minutes. A dual-wavelength approach was employed: AS detection was performed at 210 nm and MQ was detected at 283 nm, using a diode array detector. Stability of sample solutions was evaluated for 8 hours after preparation,... |
| Tipo: Info:eu-repo/semantics/article |
Palavras-chave: Artesunate/determination; Mefloquine hydrochloride/determination; High performance liquid chromatography/qualitative analysis; Fixed-dose combination tablets/qualitative analysis. |
| Ano: 2013 |
URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502013000400024 |
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