David m bliesner validating chromatographic methods

Gradient programme is 0/35, 18/35, 40/80, 45/35 and 55/35 (time (min)/%B mobile phase).

Water is taken as mobile phase-A and acetonitrile as mobile phase-B.

Norethindrone is off white, odorless, crystalline powder.

It is soluble in chloroform and dioxane, sparingly soluble in ethanol, slightly soluble in ether, practically insoluble in water.

Analytical method development and optimization The aim and objective of the present study was to develop a simple, precise, specific, accurate, stability indicating HPLC method for determination of related substances of Norethindrone tablets and their degradation products.

This is done by RP-HPLC equipped with Diode array detector (DAD).

The developed HPLC method was validated as per the International Conference on Harmonization (ICH) guidelines.

The validation parameters used are Specificity, linearity, accuracy, precision, intermediate precision, and robustness.

The developed method is stability indicating, specific, selective, simple, precise, cost effective, linear and robust.

As per reported literature there is only one analytical method available for determination of impurities for Norethindrone in Norethindrone Tablets by HPLC [2] and by UPLC [3].

The run time is more in HPLC method while UPLC is not economic and cost effective in terms of analytical column and HPLC instrument cost and availability.

Sample and standard solutions stability was also performed.

The proposed validated method was successfully used for the quantitative analysis of impurities and degradation products of Norethindrone tablets.

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