Girendra Gautam

In this review articles, the development, formulation, and manufacture of drugs, analytical method development & validation play a critical role. Methods are developed for ensuring purity, identity, potency, and performance of pharmaceutical products. Methods should be applied to the extent that they are sufficient for their intended purpose. Throughout the life cycle of a drug product and substance, a range of activities are associated with developing and validating methods. An objective of method validation is to prove that the procedure can be used as intended. Once the method is developed, validation is performed. Different national and international committees have defined the parameters for method validation. The International Conference on Harmonization attempted to harmonize pharmaceutical applications. In accordance with the ICH, other organizations define Linearity, Selectivity/Specificity, Range, Accuracy, Precision (repeatability, intermediate precision, and reproducibility), Limit of quantitation, Limit of detection, Ruggedness, and Robustness.

A rapid, simple, selective, and specific reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for estimation of Naproxen and Sumatriptan from tablet using spiked human plasma. The chromatographic separation was performed on Phenomenex Luna C18 column (5μm, 25cmx4.6mm id)  with a mobile phase comprised of Acetonitrile: Methanol: phosphate buffer pH 6 (50:10:40 v/v), at a flow rate of 1.0ml/min. The calibration curve was linear in the range of 1-3 µg/ml. The developed method was found to accurate and sensitive. Results of recovery studies prove the extraction efficiency. Stability data indicated that Sumatriptan and Naproxen was stable in plasma after three freeze thaw cycles and upon storage at −20°C for 30 days.