Development and validation of UV-spectrophotometric methods for quantitative estimation of Drotaverine HCl injection


Author(s): Yasir Mehmood, Rana Khalid Mahmood, and Waqas Akram

Introduction: The objective of this study is to develop and validate spectrophotometric method for Drotaverine HCl injection analysis. A very simple, unique, novel, protective, secured, reliable and quick method of spectrophotometric estimation in UV-region has been developed for the assay of Drotaverine HCl injection formulation. Method: Methanol and water were used as diluents for the assay of Drotaverine HCl. Results: However no interference was observed in spectrophotometric determinations. ICH guidelines were followed during selection of parameters and these were then validated statistically using neat chromate grams by RSD and %RSD. The Beer’s law was followed when 8-40 mcg/ml concentration was used. Accuracy, linearity, precision and ruggedness were used for the validation of this method. Recovery studies were used to statistically validate the proposed method. Conclusion: UV spectrophotometer was used to scan the standard solution at wavelength between 200 nm to 400 nm on spectrum mode. Maximum absorbance was found at 242 nm.

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