ANALYTICAL METHOD DEVELOPMENT AND STABILITY INDICATING STUDIES OF GEMCITABINE HCL

Method development should be based on several considerations. It is preferable to have maximum sample information to
make development fast and desired for intended analytical method application, physical and chemical properties are most
preferable as primary information. Moreover, separation goal needs to defineat beginning so appropriate method can be
developed for the purpose. An LC method development is very huge area for even pharmaceuticals with regulatory
requirement of international standards. So, prior to method validation and usage at quality control many aspects needs to
focus as per ICH guidelines. In recent time, there is incrased tendency towards the development of stability indicating
assays, using the approach of stress testing as enshrined in the International Conference on Harmonization (ICH)
guidelines. Even this approach is being extended to drug combinations to allow accurate and precise quantitation of
multiple drugs in presense of these degredent products and interaction product if any. Various publications are available
regarding the determination method of individual drugs and combinational drugs in bulk and pharmaceutical dosage forms
by spectrophotometric, HPTLC, LC-MS, UPLC and HPLC but very limited publications are available for stability
indicating methods for determination of drugs in combined dosage forms.[1-7]
The author undertaken in this studies in the area of pharmaceutical analysis and mainly addresses stability indicating
method development and validation for determination of selected drugs and in active pharmaceutical substances as well as
in pharmaceutical dosage forms by RP-HPLC. The developed methods are simple, precise, accurate, specific, selective and
more economical for the routine analysis in pharmaceutical laboratories. [8-13]