HPTLC METHOD DEVELOPMENT AND VALIDATION FOR DENSITOMETRIC ANALYSIS OF CARBOCISTEINE IN DRUG FORMULATION


Kanchan Chauhan, Ayesha Mujawar, Iram Quazi

Abstract


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.


Keywords


Carbocisteine, HPTLC method development, method validation, Mucolytic

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References


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About this article

Title

HPTLC METHOD DEVELOPMENT AND VALIDATION FOR DENSITOMETRIC ANALYSIS OF CARBOCISTEINE IN DRUG FORMULATION

Keywords

Carbocisteine, HPTLC method development, method validation, Mucolytic

Date

01-10-2016

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 8, Issue 4, 2016 Page: 22-25

Online ISSN

0975-7058

Statistics

85 Views | 78 Downloads

Authors & Affiliations

Kanchan Chauhan
Allana College of Pharmacy, Azam Campus, Camp, Pune-01

Ayesha Mujawar
Allana College of Pharmacy, Azam Campus, Camp, Pune-01

Iram Quazi
Allana College of Pharmacy, Azam Campus, Camp, Pune-01


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