Abstract

Two simple, sensitive and accurate spectrophotometric methods have been developed for the determination of bumadizone in bulk drug and its tablets. Both methods based on the oxidative coupling reaction with 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) and measuring the absorbance of the developed colors by direct or kinetic spectrophotometric method. Upon treatment of a mixture of the chromogenic reagent and drug with cerium (IV) ammonium sulfate (method I) or ferric chloride (method I), a red or violet color was developed immediately or after 30 minutes measurable at 557 nm for method I or II, respectively. The absorbance-concentration plots were rectilinear over the ranges of 1-10 μg/mL (r = 0.9999) for method I and 2-16 μg/mL (r = 0.9998) for method II. The detection limits were 0.15 and 0.27 μg/mL & the quantitation limits were 0.46 and 0.84 μg/mL for methods I and II, respectively. Different experimental parameters affecting the development and stability of the reactions products were studied and optimized. The proposed methods were applied successfully to the determination of bumadizone in its tablets, and the results obtained were in good agreement with those obtained using a comparison method.

Highlights

  • Bumadizone calcium semi-hydrate (BUM) is butylmalonic acid mono-(1,2 diphenylhydrazide) calcium semihydrate; (Fig. 1)

  • 1.2 mL 0.3 % methyl-2benzothiazolinone hydrazone hydrochloride (MBTH) solution followed by 2.5 mL 0.5 % FeCl3 solution were added and the solutions were completed to the mark with distilled water and mixed well

  • Under the described experimental conditions, BUM was found to react with MBTH in presence of Ce(IV) or FeCl3 producing red or violet colored species peaking at 557 nm for method I or II, respectively (Fig. 2)

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Summary

Introduction

Bumadizone calcium semi-hydrate (BUM) is butylmalonic acid mono-(1,2 diphenylhydrazide) calcium semihydrate; (Fig. 1). It is used as a non-steroidal anti-inflammatory drug and has a peripheral analgesic effect [1]. To the best of our knowledge ,no spectrophotometric method has been yet reported for the determination of BUM in its tablets and this initiated this study. Kinetic based methods (method II) offer many advantages other conventional ones such as, elimination of interference likely to be introduced from colored or turbid samples. They eliminate the interference of other active compounds present if they are resisting the chemical reaction conditions established for the proposed kinetic method [5-9]. 3-Methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) has been frequently utilized for spectrophotometric determination of several pharmaceutical compounds such as propranolol [6], ethamsylate [7], benazepril [8] and 4-quinolone antibacterials [9]

Materials and reagents
Procedures
Procedure for tablets
Results and discussion
Effect of concentration of MBTH
Effect of oxidizing agents
Effect of diluting solvent
Variable time measurement
Rate constant Method
Fixed absorbance method
Fixed time method
Linearity and range
Accuracy and precision
Robustness
Pharmaceutical applications
Mechanism of the reaction
Conclusion
Method II
Method I Method II
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