DEVELOPMENT AND VALIDATION OF SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL SULPHATE, AMBROXOL HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE IN COMBINED PHARMACEUTICAL TABLET FORMULATION: A NOVEL TECHNIQUE FOR IN-VITRO DISSOLUTION STUDIES

摘要

Objective: To develop a simple, rapid, accurate, precise and economical spectroscopic method for the simultaneous determination of Salbutamol Sulphate, Ambroxol Hydrochloride and Cetirizine Hydrochloride in combined pharmaceutical tablet formulation and validate as per ICH guidelines. Methods: In this method, the 6.8 pH phosphate buffer was selected for the developing spectral characteristics of the three drugs. The overlay spectra of Salbutamol Sulphate, Ambroxol hydrochloride and Cetirizine hydrochloride were resolved by making the use of simultaneous equation method based on measurement of absorbance at three wavelengths. Results: The λ max of Salbutamol Sulphate, Ambroxol Hydrochloride and Cetirizine hydrochloride were found to be 276 nm, 244 nm and 230 nm. The method obeyed Beer Lambert’s law in the concentration range of 10-100 μ g/ml for SAL, 2- 18 μ g/ml for AMB HCl and 2-20 μ g/ml for CET HCl. The high values of correlation coefficient (R) indicated good linearity of calibration plot for the drugs. Result of percentage recovery study confirms the accuracy of proposed method. Percentage RSD for precision and accuracy of the method was found to be less than 2%. LOD values for SAL, AMB, and CET were found to be 0.523 ??g/mL, 0.450 ??g/mL and 0.457 ??g/mL, respectively. LOQ values for SAL, AMB, and CET were found to be 1.372 ??g/mL, 1.424 ??g/mL and 1.386 ??g/mL, respectively. Conclusion: A rapid, economical, accurate, precise and reproducible simultaneous equation spectroscopic method was developed and validated. The proposed method can be employed for routine analysis of Salbutamol Sulphate, Ambroxol Hydrochloride and Cetirizine Hydrochloride in combined pharmaceutical tablet formulation. Keywords: Salbutamol Sulphate, Ambroxol Hydrochloride, Cetirizine Hydrochloride, Simultaneous equation, Absorbtivity, Absorbance, Absorption Maxima . , ICH guidelines, Validation.