Development and Validation of a Simple and Reliable UV Spectrophotometric Method for the Simultaneous Estimation of Metformin Hydrochloride and Pravastatin Sodium | Chapter 9 | Pharmaceutical Science: New Insights and Developments Vol. 10

 

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.

 

 

Author(s) Details

Ankita Sharma
Shiva Institute of Pharmacy, Bilaspur, H.P., India.

 

Kapil Kumar Verma
Minerva College of Pharmacy, Indora, Kangra, H.P., India.

 

Inder Kumar
Minerva College of Pharmacy, Indora, Kangra, H.P., India.

 

Anju Bala
Chandigarh Group of Colleges Landran, Kharar, Greater Mohali, Punjab, India.

 

Bhumika Thakur
Shiva Institute of Pharmacy, Bilaspur, H.P., India.

 

Vandana Thakur
Abhilashi College of Pharmacy, Nerchowk, Mandi, H.P., India.

 

Please see the book here :- https://doi.org/10.9734/bpi/psnid/v10/7061

A Combination Therapy for Diabetes Miletus Using Metformin Hydrochloride and Gliclazide Bilayer Tablets | Chapter 3 | Pharmaceutical Research - Recent Advances and Trends Vol. 4

 

Objective: The main objective of the present investigation is to develop combination therapy for Type II Diabetic subjects using bilayer sustained release formulation of metformin hydrochloride (MFH) and gliclazide (GLZ) based on monolithic-matrix technology.

 

Methods: Bilayer tablets were prepared by the wet granulation method. Initially, metformin HCl layer and gliclazide layers were optimized using release retardants like Polyox WSR coagulant and different viscosity grades of hydroxyl propyl methyl cellulose (HPMC) and evaluated for in vitro dissolution performance and drug excipient studies separately. The optimized formulations were selected and compressed to bilayer tablets to achieve the desired sustained release in combination.

 

Results: Metformin hydrochloride and gliclazide showed sustained release of drug by diffusion mechanism and followed first-order kinetics. The best formulation of metformin hydrochloride (M7) and gliclazide (G8) shows 99.93% and 99.65% of drug release in 24 h respectively. The similarity factor (f2) was 89.95 for metformin hydrochloride and 83.62 for gliclazide when compared to the innovator. FTIR studies reveal the absence of significant interactions indicating drug excipient compatibility.

 

Conclusion: The monolith diffusion-controlled bilayer tablets of metformin hydrochloride and gliclazide offer improved patient compliance and convenience with better postprandial hyperglycemic control with once-a-day dosing. The sustained release of the drug up to 24 h regulates antidiabetic activity round the clock with minimal side effects.

 

Author(s) Details

Rajeswari Aleti
Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy, Hyderabad 500090, India.

Sailaja Gunnam
Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy, Hyderabad 500090, India.

Monika Nijhawan
Department of Pharmaceutics, Gokaraju Rangaraju College of Pharmacy, Hyderabad 500090, India.

 

 

Please see the book here:- https://doi.org/10.9734/bpi/prrat/v4/1115