Volume : 13, Issue : 05, May – 2026
Title:
A NEW SIMPLE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF ANTI-DIABETIC DRUG LINAGLIPTIN IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS BY USING RP-HPLC
Authors :
Bigulla Shirisha*, G. Kalyani, Vijaya Kuchana, Pasupuleti Sunitha
Abstract :
A simple, selective, rapid and precise reversed-phase high-performance liquid chromatographic method for analysis of Linagliptin in bulk and tablet dosage form has been developed and validated. Chromatography was performed on a Waters C18, 5µm particle size, 25cmx4.6mm i.d. with Phosphate buffer (pH adjusted to 5.8 with orthophosphoric acid): Acetonitrile in the ratio of 45:55 v/v as mobile phase at a flow rate of 1.0 mL min−1. UV detection was performed at 243 nm. Total run time was 9.0 min. Linagliptin were eluted with retention time of 4.398 minutes. The method was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with USP and ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the concentration ranges 0-50μgmL−1 for Linagliptin. Limit of detection were 0.003mg mL−1 and limit of quantification were 0.009mg mL−1 for Linagliptin. The high recovery and low coefficients of variation confirm the suitability of the method for analysis of the drug in tablet dosage form. The validated method was successfully used for quantitative analysis of Linagliptin in marketed pharmaceutical dosage forms.
Key Words: Linagliptin, RP-HPLC, Method Development, Accuracy, Precision.
Cite This Article:
Please cite this article in press Bigulla Shirisha et al., A New Simple Analytical Method Development And Validation For The Quantitative Estimation Of Anti-Diabetic Drug Linagliptin In Bulk And Marketed Pharmaceutical Dosage Forms By Using Rp-Hplc.., Indo Am. J. P. Sci, 2026; 13(05).
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