NEW TITRIMETRIC AND SPECTROPHOTOMETRIC METHODS FOR THE ASSAY OF PROCHLORPERAZINE IN PHARMACEUTICALS USING N-CHLOROSUCCINIMIDE AND TWO DYES
One titrimetric and two spectrophotometric methods are described for the assay of prochlorperazine mesylate(PCPM) in bulk drug and in injection using N-chlorosuccinimide(NCS) and two dyes, methyl orange and indigo carmine as reagents. In titrimetry, aqueous solution of PCPM is titrated directly with...
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| Autores principales: | , |
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| Lenguaje: | English |
| Publicado: |
Sociedad Chilena de Química
2007
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| Materias: | |
| Acceso en línea: | http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072007000400005 |
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| Sumario: | One titrimetric and two spectrophotometric methods are described for the assay of prochlorperazine mesylate(PCPM) in bulk drug and in injection using N-chlorosuccinimide(NCS) and two dyes, methyl orange and indigo carmine as reagents. In titrimetry, aqueous solution of PCPM is titrated directly with a standard solution of NCS in acid medium and in the presence of potassium bromide(KBr). Spectrophotometric methods entail the addition of a known excess of NCS to a solution of PCPM in acid medium and in the presence of KBr followed by determination of residual bromine by reacting with a fixed amount of either methyl orange and measuring the absorbance at 520 nm (method A) or indigo carmine and measuring the absorbance at 610 nm (method B). In all the methods, the amount of NCS reacted corresponds to the amount of PCPM. In titrimetry, the reaction stoichiometry was found to be 1:1 (PCPM: NCS) and is applicable over 3.5-20 mg range. In spectrophotometric methods, the absorbance was found increase linearly with PCPM concentration with the correlation coefficients of 0.9986 and 0.9993 for method A and method B, respectively. The systems obey Beer's law for 0.25-3.0 µg/mL (method A) and 0.5-8.0 µg/mL (method B). The calculated apparent molar absorptivity values are 1.11 x10(5) and 4.49 x10(4) L/mol/cm for method A and method B, respectively, and the corresponding Sandell sensitivity values are 0.005 and 0.013 ug/cm². The limits of detection and quantification are reported for both spectrophotometric methods. Intra-day and inter-day precision and accuracy of the methods were evaluated as per ICH guidelines. The methods were successfully applied to the determination of PCPM in injection, and the results were statistically compared with those of a reference method by applying Student's t- test and F-test. No interference was observed from common additives found in injection solution. The accuracy and reliability of the methods were further ascertained by performing recovery test via standard addition method |
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