Development and Validation of a Simple and Reliable UV Spectrophotometric Method for the Simultaneous Estimation of Metformin Hydrochloride and Pravastatin Sodium

Background: Metformin hydrochloride is a drug used in the treatment of type 2 diabetes. It exhibits high aqueous solubility, limited solubility in ethanol, and negligible solubility in organic solvents such as acetone, ether, and chloroform. Aim: A straightforward and reliable ultraviolet (UV) spectrophotometric method was developed and validated for the simultaneous estimation of Metformin Hydrochloride (MH) and Pravastatin Sodium (PS) in their pure forms. Methodology: The proposed method employs an absorbance subtraction approach using UV spectrophotometry. Quantification was carried out by measuring absorbance at two selected wavelengths, 232 nm for Metformin Hydrochloride and 238 nm for Pravastatin Sodium. Method validation was performed in accordance with ICH guidelines, including accuracy studies conducted at three concentration levels (75%, 100%, and 125%), and percentage recovery was calculated for both drugs. Results: The method demonstrated acceptable sensitivity, with limits of detection and quantification determined as 0.481 μg/mL and 0.670 μg/mL for MH, and 1.15 μg/mL and 1.68 μg/mL for PS, respectively. Statistical evaluation of validation parameters confirmed that the method exhibited satisfactory precision, accuracy, and selectivity within the specified limits. Conclusion: The validated UV spectrophotometric method is simple, precise, and accurate, making it suitable for the simultaneous estimation of Metformin Hydrochloride and Pravastatin Sodium. The method can be effectively applied for routine analysis of these drugs in pure form and pharmaceutical dosage formulations.