APPLICATION OF CHEMOMETRIC METHODS FOR THE DETERMINATION OF CIPROFLOXACIN HYDROCHLORIDE AND PHENAZOPYRIDINE HYDROCHLORIDE IN THEIR PHARMACEUTICAL DOSAGE FORM

摘要

For simultaneous analysis of Ciprofloxacin Hydrochloride (CIP), phenazopyridine Hydrochoride (PHE), in its drugdose type, chemometric-assisted UV spectrophotometric methods have been established and validated.The chemometric methods used were partial least square (PLS) regression, principal component regression (PCR) and classical least square (CLS) models.Two sets of standard mixtures, calibration sets and validation sets have been prepared.All three models have been optimized to quantify each drug in the mixture using the information included in the UV absorption spectra of the appropriate solution in the range of 205-515 nm with the range of 5 nm.Optimized models have been successfully applied to the simultaneous estimation of these drugs in synthetic mixture and pharmaceutical dosage form.The methods were validated in linearity, precision, sensitivity, specificity and robustness in the range of 5-25μg / ml for CIP and 4-20μg / ml for PHE for spectrophotometric-assisted UV chemometrics as per the ICH guideline.The PLS, PCR, CLS methods developed were used to determine CIP and PHE in tablets.