Research Article

Quality by Design Approach for the Development and Validation of Glipizide, an Antidiabetic Drug, by RP-UPLC with Application to Formulated Forms and Urine

Table 1

Screening: summary of method selection*.

S. no.Column ObservationsRemarks

1Acquity BEH C8 (100 × 2.1) mm, 1.7 µmAsymmetrical peak with fronting and tailingNot satisfactory
2Acquity BEH C18 (100 × 2.1) mm, 1.7 µmAsymmetrical peak with tailingNot satisfactory
3Acquity HSS cyano (50 × 2.1) mm, 1.7 µmSplit peakNot satisfactory
4Acquity HSS BEH shield RP18 (50 × 2.1) mm, 1.7 µmAsymmetrical peak Not satisfactory
5Zorbax Extend C-18 (50 × 4.6) mm, 1.8 µmSymmetrical peaksatisfactory

 *By keeping one column constant, the mobile phase, temperature, buffer, and sample concentration parameters were changed.