Asian Journal of Pharmaceutical Analysis

K. Raghubabu ¹, V. Jagannadharao ², B. Kalyana Ramu ³

Affiliations
1 Department of Engineering Chemistry, AU College of Engineering (A), Andhra University, Visakhapatnam-530003, Andhra Pradesh, IN
2 Department of Chemistry, Anil Neerukonda Institute of Technology and Sciences, Sangivalasa (AP), IN
3 Department of Chemistry, Maharajah’s College (Aided and Autonomous), Vizianagaram-535002 (AP), IN

Abstract

Two simple and sensitive direct visible spectrophotometric methods (M₁ and M₂) have been developed for the determination of Ropinirole hydrochloride in bulk and solid dosage forms. These methods are based on the reaction of drug with aromatic aldehydes such as Vanillin or Para dimethyl amino Benzaldehyde (PDAB) in the presence of sulphuric acid in non aqueous medium and formed colored condensation products with an absorption maximum of 560nm for method M₁ and 660nm for method M₂. The Beer's law obeyed in the concentration range of 5-20μg/ml for method M₁ and 25-150μg/ml for method M₂. The proposed methods are validated with respect to accuracy, precision, linearity and limit of detection. The suggested procedures are successfully applied to the determination of the drug in pharmaceutical preparation, with high percentage of recovery, good accuracy and precision. The results of analysis have been validated statistically by repeatability and recovery studies. The results are found satisfactory and reproducible. These methods are applied successfully for the estimation of ropinirole hydrochloride in tablet dosage form without the interference of excipients.

Keywords

Analysis, Beer’s Law, Condensation Reactions, Non-Ergoline Dopamine Antagonist, Tablets.

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U. Viplava Prasad ¹, M. Syam Bab ¹, B. Kalyana Ramu ²

Affiliations
1 Department of Organic Chemistry and Analysis of Foods Drugs and Water Laboratories, School of Chemistry, Andhra University, Visakhapatnam-530003 Andhra Pradesh, IN
2 Department of Chemistry, Maharajah’s College (Aided and Autonomous), Vizianagaram-535002 (AP), IN

Abstract

Purpose: The aim of the investigation was to see the simple and sensitive visible spectrophotometric method for the determination of the sapropterin dihydrochloride either in bulk or tablet dosage forms. Method: A simple, sensitive indirect visible spectrophotometric method has been developed for the estimation of sapropterin dihydrochloride in bulk and dosage forms. The method is based on the oxidation of drug with excess N-Bromo succinimide and determining the unreacted NBS with an oxidisable dye Celestein blue by spectrophotometrically at 522nm Results: Beer's law obeyed in the concentration range of 4-12 μg/ml. No interference was observed from the usually existing additives in pharmaceutical formulations and the applicability of the method was examined by analyzing kuvan tablets containing SAP. Conclusion: The reported methods for its assay involve sophisticated equipment, which are very costly and pose problems of maintenance. To overcome these problems, the use of visible spectrophotometric technique is justifiable. The statistical data indicates the accuracy, reproducibility and the precision of the proposed method.

Keywords

Assay, Beer’s Law, Regression Equation, Spectrophotometer, Tablets.

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