New spectrophotometric Q-Absorbance Ratio method has been developed for the simultaneous determination of Phenylephrine HCl and Bromhexine HCl in tablet dosage form. The various parameters, such as linearity, precision, accuracy, limit of detection and limit of quantitation were studied according to International Conference on Harmonization (ICH) guidelines. The Iso-absorptive point was found to be 218 nm. Calibration curves were linear over a concentration range of 5-15 μg/ml for Phenylephrine HCl and 4-12 μg/ml for Bromhexine HCl respectively. Accuracy of method was determined through recovery studies which were found 98.10-100.24 % for Phenylephrine HCl and 98.11 – 99.01 % for Bromhexine HCl. Method was found to be reproducible with relative standard deviation (RSD) for intra and interday precision to be < 1.5% over the said concentration rang.LOD and LOQ were found to be 0.958-2.904 to 240nm for PLE and 0.467-1.415 to 240nm for BHX. The proposed method is found to be highly simple, sensitive, precise and accurate.
Development And Validation Of Q-Absorbance Ratio Method For Simultaneous Estimation Of Phenylephrine Hcl And Bromhexine Hcl In Pharmaceutical Dosage Form
Research Article
DOI:
xxx-xxxxx-xxxx
Subject:
science
KeyWords:
Phenylephrine HCl, Bromhexine HCl, Q-Absorbance ratio method, Analytical method validation,
Abstract: