HPTLC METHOD DEVELOPMENT AND VALIDATION FOR DENSITOMETRIC ANALYSIS OF CARBOCISTEINE IN DRUG FORMULATION
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.
2. Walash MI, Amina M-EB, Mohamed EM, Amina AA. Fluorimetric determination of carbocisteine and ethionamide in drug formulation. Acta Chim Slov 2004;51:283âˆ’91.
3. Walash MI, Amina M-EB, Mohamed EM, Amina AA. Spectrophotometric determination of penicillamine and carbocisteine based on the formation of metal complexes. IL FARMACO 2004;59:493â€“503.
4. Wahl O, Holzgrabe U. Impurity profiling of carbocisteine by HPLC-CAD, qNMR and UV/vis spectroscopy. J Pharm Biomed Anal 2014;95:1-10.
5. Nikolaos CM, Michael AK. Ion chromatographic determination of carbocisteine in pharmaceuticals based on the non-suppressed conductimetric detection. J Chromatogr A 2004;1026:167-74.
6. Rele RV, Patil SP. Reversed phase high-pressure liquid chromatography technique for determination of carbocisteine from the pharmaceutical formulation. J Chem Pharm Res 2010;2:24-30.
7. Sarode SK, Pise ST, Dhore P, Mundhada DR, Bhaskaran S. Development of an analytical method for simultaneous estimation of amoxicillin and carbocisteine in solid dosage form by RP-HPLC. Biomedrx 2013;1:360-2.
8. Bron J. HPLC determination of carbocisteine in Human Plasma. Pharm Weekbl Sci 1986;8:134-8.
9. Argekar AP, Raj SV, Kapadia SU. Simultaneous determination of cephalexin and carbocisteine from capsules by reverse phase high-performance liquid chromatography. Anal Lett 1997;30:821-31.
10. Nadimintri A, Gunda A, Karnaker RT, Abbaraju PL, Kedarnath JA, Nagubandi S. Simultaneous estimation of amoxicillin trihydrate and carbocisteine drug present in the formulation by RP-HPLC method and its validation. J Pharm Res 2012;13:1889-95.
11. Burugu R, Venkateshwarlu G. A stability indicating ultra-performance liquid chromatography method for the determination of assay of carbocisteine in various formulation products. Int J Pharm Pharm Sci 2012;4:653-6.
12. Li Rui. Determination of carbocisteine tablets by HPLC. Chin Pharm; 2006. p. 6.
13. International Conference on Harmonization (ICH), Q2 (R1) Validation of Analytical Procedures: Text and Methodology, ICH Harmonized Triapartite Guideline; 2005.