A Stability Indicating RP-HPLC Method Validation for Simultaneous Estimation of Linagliptin and Empagliflozin in Pharmaceutical Dosage Form

Aims: Linagliptin and Empagliflozin are a new medicine combination for the treatment of Diabetes Mellitus, one of humanity’s oldest and most fatal diseases. The goal of this study was to develop and validate a new, quick, sensitive, specific, and stable stability indicating analytical approach for the simultaneous estimation of Linagliptin and Empagliflozin in a fixed dose pharmaceutical dosage form.

Study Design: The ICH guideline “Validation of analytical procedures: Test and Methodology Q2(R1)” was followed for method development and validation.

Methodology: The method was developed using a phenyl column (150mm 4.6 mm, 3.5 mm particle size), a 30°C column temperature, an HPLC system with a PDA detector, and a degassed mixture of 0.1 percent perchloric acid: acetonitrile (75:25 v/v) as the mobile phase. With responses measured at 226 nm, the flow rate was set to 1.2 ml/min, the injection volume was 20 l, and the run time was 22 minutes.

Linagliptin and Empagliflozin had retention times of 10.2 and 15.7 minutes, respectively. With correlation values more than 0.999, linearity was established in the range of 10-30 g/ml for Linagliptin and 20-60 g/ml for Empagliflozin. Linagliptin and Empagliflozin had percentage recoveries of 98.4-100.5 percent and 99.2-100.4 percent, respectively. The International Conference on Harmonization (ICH) Q2 R1 criteria were used to evaluate the validation parameters. HCl, NaOH, H2O2, heat, and UV radiation were used in the forced degradation investigations. The created method was used to perform quantification and hyphenated instrumental analysis with great success.

Conclusion: The developed method’s significance lies in the fact that it may be used for routine or unknown sample analysis of Linagliptin and Empagliflozin in pharmaceutical dosage forms offered by diverse pharmaceutical companies.

Author(S) Details

Darshak Patel
Department of Quality Assurance & Pharm. Chem., Faculty of Pharmacy, Nootan Pharmacy College, Sankalchand Patel University, S. K. Campus, Visnagar-384315, Gujarat, India.

Ujashkumar Shah
Department of Quality Assurance & Pharm. Chem., Faculty of Pharmacy, Nootan Pharmacy College, Sankalchand Patel University, S. K. Campus, Visnagar-384315, Gujarat, India.

Jayvadan Patel
Department of Quality Assurance & Pharm. Chem., Faculty of Pharmacy, Nootan Pharmacy College, Sankalchand Patel University, S. K. Campus, Visnagar-384315, Gujarat, India.

Darshana Patel
Department of Quality Assurance & Pharm. Chem., Faculty of Pharmacy, Nootan Pharmacy College, Sankalchand Patel University, S. K. Campus, Visnagar-384315, Gujarat, India.

Pavan Patel
Restech Pharmaceuticals, Plot No. 407 New Ahmedabad Industrial Estate, Sarkhej-Bavala Road, Moraiya-382 210, Dist-Ahmedabad, Gujarat, India.

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