Validated UV-spectrophotometric estimation of diclazurilin API and drug product

Taghreed M. Ibrahim

Abstract

Validated UV-spectrophotometric estimation of diclazurilin API and drug product

Author(s): Taghreed M. Ibrahim

Three simple, precise, accurate, and economical UV spectrophotometric methods have been developed and validated for the routine estimation of diclazuril in active pharmaceutical ingredient (API) and drug product. Diclazuril was estimated at 286.2 nm in UV-spectroscopic method (Method A), 260 nm in first order derivative spectroscopy (Method B) and scanned at 300 – 273 nm in Area Under Curve method (Method C).Linearity range was found to be 2 -22 μg/ml (Correlation coefficient r2 = 0.9996 in method A, r2 = 0.09997 in method B and r2 = 0.9995 in method C) in all three methods. The molar absorptivity was found to be 1.6x104 Lmol-1 cm-1 in method A, 2.038x103 Lmol-1 cm-1 in method B, and 5.5x104 Lmol-1 cm-1 in method C. These methods were tested and validated for various parameters according to ICH guidelines. The proposed methods were successfully applied for the determination of Diclazuril in drug product (powder). The results demonstrated that the procedure is accurate, precise and reproducible (% relative standard deviation < 1%), while being simple, cheap and less time consuming and can be suitably applied for the estimation of Diclazuril in powder dosage forms.

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