QbD Stressed Development and Validation of Stability-Indicating RP- HPLC Method for the Simultaneous Estimation of Linagliptin and Metformin HCl in Pharmaceutical Dosage Form

• DOI: 10.52711/0974-360x.2022.00319
• Publication Date: 2022-06-14T07:33:08Z
• Authors: Khushbu Patel; Ujashkumar A. Shah; Hirak V. Joshi; Jayvadan K. Patel; Chhaganbhai N. Patel
• Keywords: Linagliptin; Quality by Design; Chromatographic Separation

A new simple stability indicating reverse phase liquid chromatography method was developed by employing Quality Design (QbD) approach for the simultaneous determination of Linagliptin and Metformin HCl. Within QbD paradigm, present study aimed to establish optimization RP-HPLC (Reverse high performance chromatography) means design experiments response surface mythology like, Centre composite (CCD) in order achieve a good separation resolution. The is effective separate HCl with chromatographic resolution 6.4. Chromatographic acquired column Water C18 (250mm x 4.5mm 5μm) at flow rate 1.0 ml/min mobile consists acetonitrile methanol (75:25 % v/v). detection carried out 245nm. proposed validated according ICH guidelines. linear range 0.5-3μg/ml 100-600μg/ml respectively recovery were 98% 102%. degradation product found stress patterns well separated among drug compounds. be specific, rapid, precise robust routine analysis its pharmaceutical dosage form.