Asian Journal of Pharmaceutical Analysis

K. Vijaya Sri ¹, M. Anusha ¹, S. Ravinder Reddy ¹

Affiliations
1 Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Maisammaguda, Secunderabad-500 014, Telangana, IN

Abstract

A simple, precise, accurate and robust RP-HPLC-UV method was developed and validated for the determination of Linagliptinin tablet dosage forms. Reverse-phase chromatography was performed on Agilent (100 mm × 2.5 mm, 3μm) column of C18 HPLC with EZ Chrome software with UV detector. Methanol: water containing 0.1% ortho phosphoric acid (70:30) (v/v) was used as mobile phase at a flowrate of 0.8 mL min^-1 with UV detection at 296 nm. Linearity was observed in the concentration range of 2.5- 15 μg mL^-1 with correlation co-efficient (R² = 0.999). The method was validated as per ICH guidelines. The RSD for intra-day (0.254) and inter-day (0.2449) precision were found to be less than 2 %. The percentage recovery was in good agreement with the labelled amount in the pharmaceutical formulations and the method is simple, precise, accurate and robust for the determination of Linagliptinin pharmaceutical dosage forms.

Keywords

Linagliptin; RP-HPLC-UV, Method Validation, Tablets.

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K. Vijaya Sri ¹, S. Sruthi ¹, M. A. Madhuri ¹

Affiliations
1 Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, (Affiliated to Osmania University) Maisammaguda, Secunderabad-500 014, IN

Abstract

A simple, fast, precise and accurate RP-HPLC by internal standard method were developed and validated for the estimation of Tolvaptan as per ICH guidelines. Methanol: 0.2M phosphate buffer (70:30v/v) was used as the solvent. Sumatriptan was selected as an internal standard. The method was developed in Eclipse C₁₈ column (100 mm × 4.6 mm, 3.5 μm particle size). The method was found to be linear in the range of 5-100μg/ml with a correlation coefficient value of 0.999. The accuracy studies of RP-HPLC by internal standard method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range 99.01 to 100.7%. The % RSD is <2% which indicates the accuracy and precision of the method. The above method was a rapid tool for routine analysis of Tolvaptan in the bulk and in the pharmaceutical dosage form.

Keywords

Tolvaptan, RP-HPLC Method, Internal Standard, Development, Validation and Pharmaceutical Formulation.

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