Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BROMHEXINE HYDROCHLORIDE USING U.V. SPECTROPHOTOMETRIC METHOD

Syeda Juveria Yasmeen*, Tahmina Sultana, Akthar Sulthana M., Abdul Saleem Mohammad, Shaik Sajeed, Syed Ashfaq Hussain

ABSTRACT

Pharmaceutical analysis occupied a pivotal role in the determination of drugs in formulation and its combinations. The complexity of problems in existing methods in terms of achieving the selectivity, speed, simplicity, sensitivity, precision and accuracy has been replaced by methods of analysis. The present work attempts to minimize the time consumption and cost by simple spectrophotometric method based on use of Methanol and Formic Acid solution in which the drug Bromhexine Hydrochloride is completely soluble used a solvent system. The drug has an absorption max at 277 nm and obeys Beers Lamberts law. The absorbance was to found to increase linearly with increasing concentration of Bromhexine Hydrochloride which is corroborated by the calculated correlation coefficient value of 0.9997. The Molar Absorptivity is 2.01468±0.13778 (Mean± SD). The slope and intercept of the equation of the regression line are 0.0434, 0.0223. The mean recovery obtained for the drug was found to be in the range of 99.77-100.05%. The optimum experimental parameters for the method have been studied. The validity of the elucidated method was accessed according to the International Conference on Harmonization Guidelines. Statistical analysis of the results has been carried out revealing high accuracy and good precision. The proposed method can be applied to the Determination of Bromhexine Hydrochloride in the Pharmaceutical dosage forms. Literature survey reveals that there is a need to develop new, simple, specific, reliable analytical methods for determination of Bromhexine Hydrochloride in pure and pharmaceutical dosage form.

Keywords: Ultra Violet Spectroscopy, Active Pharmaceutical Ingredient, Limit of Detection, Limit of Quantitation, Coefficient of Variation.


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