Stability indicating HPLC method development and validation for Simultaneous estimations of some Combination Dugs: A Review
Mohd. Farooquea* and Gulam Javed Khanb
aU.B.K.W.T’s D. Pharmacy College, Kunjkheda, Dist-Aurangabad - 431001 (India) bAli Allana College of Pharmacy, Akkalkuwa KBC NMU, Jalgaon - 425415 (India)
ABSTRACT
One form of liquid chromatography is high performance liquid chromatography (HPLC). It can separate labile natural products, polymeric materials, ionic species, and macromolecules. The ICH criteria for the assessment of pharmaceutical formulations and medicines in bulk can be followed in the development and validation of the stability indicating HPLC method. An overview of the development and validation of the HPLC method for drug estimation can be found in the various published literature. Different experiments, such as altering the concentration of the mobile phase, the detecting wavelength, and the flow rate, can be used to develop the HPLC process. The generated approach will then undergo validation using various factors. Several metrics, including linearity, accuracy, precision, repeatability, robustness, LOD, and LOQ, can be used to validate the HPLC method.It is also necessary to carry out forced degradation studyto predict, evaluate, and ensure drug product safety. This stability indicating developed method can be used for routine analysis of drugs in bulk and pharmaceutical formulation.