Stability Indicating Chromatographic Methods.

      Аннотация: In a current scenario of a drug research and development, regulatory requirement is very stringent and much of importance that any new or established drug / drug formulation must remain stable till it will utilize by a patient. The stability issues are greatly influence the drug’s therapeutic property hence it is important to maintain the all the factors and parameters which may alter the drugs physico-chemical properties. To study the effect of various environmental factors on drug stability, stability indicating method play vital role. In presented work we have mainly discussed two stability indicating analytical methods for single drug and drugs available in combinations. HPLC and HPTLC methods were developed and validated for the estimation of selected drugs. Selected drugs were acted upon various stressed conditions including acidic, alkali, photo, thermal etc and possible stability issues were studied. The developed methods were validated according to ICH guideline as it is universally accepted guideline for drug stability. Developed chromatographic methods were statistically compared and found that there were no any statistical difference amongst them.

Ключевые слова: Analytical Method, application, Drugs, validation