HPTLC METHOD DEVELOPMENT AND VALIDATION FOR DENSITOMETRIC ANALYSIS OF CARBOCISTEINE IN DRUG FORMULATION
DOI:
https://doi.org/10.22159/ijap.2016v8i4.13631Keywords:
Carbocisteine, HPTLC method development, method validation, MucolyticAbstract
Objective: Development of a simple, selective, precise, high-performance thin layer chromatographic method for the analysis of carbocisteine, mucolytic drug in pharmaceutical dosage form.
Methods: The proposed HPTLC method employed TLC aluminum plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of butanol: water: ethanol: acetic acid (5:1.5:2:1.5 v/v/v/v). This system was found to give compact spots for carbocisteine with Rf value of 0.34.
Results: The reported method is linear over the range of 50-800 ng/spot with a coefficient of correlation 0.9992. The precision study revealed that the percentage relative standard deviation was within the acceptable limit. The developed method was validated according to ICH Guidelines.
Conclusion: An economical, accurate, sensitive and precise HPTLC method was developed and fully validated for quality control analysis of carbocisteine in tablets. The developed method was validated with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy and robustness. Validation results were found to be satisfactory. The proposed method can be used for routine analysis of carbocisteine in quality control laboratories.
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