Spectrophotometric estimation of ambroxol hydrochloride and cetirizine hydrochloride in tablets

Neela Manish Bhatia, Santosh Kumar Ganbavale, Harinath Nivrutti More

Abstract


A simple, rapid, accurate, precise and reproducible simultaneous equation method has been developed for simultaneous estimation of ambroxol hydrochloride and cetirizine hydrochloride in tablets. Ambroxol hydrochloride has absorbance
maxima at 243 nm, while cetirizine hydrochloride has absorbance maxima at 229 nm in glass-distilled water. The method developed involves no separation or extraction process.The proposed methods were successfully applied to the determination of ambroxol hydrochloride and cetirizine hydrochloride in tablets, with high percentage of recovery, good accuracy, and acceptable precision. Different analytical performance parameters such as linearity, precision, accuracy, limit of detection, limit of quantitation, and robustness were determined according to International Conference on Harmonization ICH Q2B guidelines. Results of analysis of formulation given as percentage of label claim ± relative standard deviation were found to be 99.27 ± 0.8083 and 102.43 ± 1.5357 for ambroxol hydrochloride and cetirizine hydrochloride respectively. Results
of recovery studies given as percentage of label claim ± relative standard deviation were found to be 99.88 ± 0.3811 and 100.36 ± 2.0480 for ambroxol hydrochloride and cetirizine hydrochloride respectively.


Full Text:

PDF

References


Reynolds JE, et al. Martin dale-the extra pharmacopoeia, 31st ed. London:Royal Pharmaceutical Society; 1996. p. 1062.

Reddy MN, Rao KV, Swapna M, Sankar DG, Spectrophotometric

determination of ambroxol. East Pharm 1998;48:125-6.

Indrayanto G, Handayani R, Quantitative determination of ambroxol

hydrochloride in tablets. J Pharma Biomed Anal 1993;11:781-4.

Heinanen M, Barbas C. Validation of an HPLC method for the

quantification of Ambroxol hydrochloride and benzoic acid in a syrup

as pharmaceutical form stress test for stability evaluation. J Pharma

Biomed Anal 2001;24:1005-10.

Botterblom MH, Janssen TJ, Guelen PJ. Rapid and sensitive determination of ambroxol in human plasma and urine by high-performance liquid chromatography. J Chromatogr 1987;421:211-5.

Zaater MF, Tahboub YR, Najib NM, RP-LC method for the determination

of cetirizine in serum. J Pharma Biomed Anal 2000;22:739-44.

Lakshmi K, Niraimathi V, High performance thin layer chromatographic

determination of cetirizine and ambroxol in tablets. Indian Drugs

;40:227-30.




DOI: http://dx.doi.org/10.22377/ajp.v2i3.210

Refbacks

  • There are currently no refbacks.