ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR CONTROL OF PH AND ELECTRICAL CONDUCTIVITY IN SALBUTAMOL SOLUTIONS

Main Article Content

Sidra Rafique
Mudassar Mazher
Abdul Quddoos
Kishwar Sultana
Syed Hassan Murtaza Naqvi
Muhammad Rehan Malik
Zafar Iqbal
Muhammad Shahzad Khan
Hosh Muhammad Lashari

Keywords

Method Development, Validation, control of in salbutamol solutions, control of electrical conductivity in salbutamol solutions

Abstract

Analytical method development and validation play an important role in the discovery, development, and manufacturing of pharmaceuticals. The process validation is of utmost importance while manufacturing a quality product. Salbutamol sulfate (SBS) is a very potent bronchodilator and is used extensively for treating different respiratory problems such as bronchial congestion, asthma and Chronic Obstructive Pulmonary Disease (COPD), etc.  In this study, a method of need was developed for prospects to be used for better advances in solution stability and preservation by controlling pH and electrical conductivity. This method was developed using a pH/conductivity meter of accuracy ±0.02 and all procedures were done by maintaining the temperature of the solution at 25°C. The de-ionized water was used as a solvent to minimize any contaminant ions activity. During method development, the development, measurement and validation of the pH and electrical conductivity were performed. For developing a method for control the pH value of the solution was maintained at 5.00 so that the results show that the method developed is precise and accurate. Different validation parameters were studied such as linearity, accuracy, precision and robustness. The method was validated according to standard guidelines. The routine calibration of the pH/conductivity meter was done to obtain accurate readings and to avoid any mishandling of any step throughout the process. The results were precise and showed that the method developed is accurate. The method developed is suitable for the control of pH and electrical conductivity for the different solutions as these characteristics are necessary for their stability, quality and efficacy. The method developed is precise, stable and also enhances the action of salbutamol sulfate. It can serve as a new window for researchers to analyze and control the pH and conductivity of different formulations.

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