Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient's (API's). Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, HPTLC, AAS etc. Conventional Liquid Chromatography, particularly, HPLC has been exploited widely in field of impurity profiling; the wide range of detectors, and stationary phases along with its sensitivity and costeffective separation have attributed to its varied applications. Among the various Planar Chromatographic Methods; TLC is the most commonly used separation technique, for isolation of impurities; due to its ease of operation and low cost compared to HPLC. An advancement of thin layer chromatography HPTLC, is a well-known technique for the impurity isolation. Headspace GC is one of the most preferred techniques for identification of residual solvents. The advent of hyphenated techniques has revolutionized impurity profiling, by not only separation but structural identification of impurities as well. Among all hyphenated techniques, the most exploited techniques, for impurity profiling of drugs are LC-MS-MS, LC-NMR, LC-NMR-MS, GC-MS, and LC-MS.

The review article deals with theoretical aspects of Derivative UV-Spectrophotometry. The method gains significance using the first and second derivative of the transmission spectra with respect to wavelength. Generated optical derivatives are compared to the known numerical derivatives. The derivative spectra from 1 st to 4 th are consequently discussed. This provides valuable insight into the uses and limitations of this technique for chemical analysis. Measurement techniques and methods of obtaining derivative spectra are discussed. The degree of polynomial fit on the smoothness of derivative spectra and signal-to-noise ratio is described. Application of UV derivative spectrometry for determination of single and multicomponent analysis is shown. Derivative spectrophotometry possibly improves the selectivity and sensitivity of determination which has been illustrated.

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The results validate in vivo and in vitro antidiarrheal activity of Berberis aristata extracts and provide its chemical fingerprint.

AbstractThis review presents the essential brief annals, crucial analytics, precise applications and noteworthy implications of design of experiments which enrouted to liquid chromatography (LC) in the midst of utmost focus on high-performance liquid-chromatography (HPLC) and broadened its impressions on allied techniques in pharmaceutical analysis. Being most widely applied statistical methodologies for such purpose, its use was started in 1970 and heightened after Fischer’s precious input in 1981. The persistent use of statistical approaches one after another led to the efficient attention of pharmaceutical analysts. Hence, in order to fine-tune the trail impressed by the cumulative trends, the use of statistical designs in HPLC analysis has been reviewed and efforts were made to recognize its relative impact and corresponding future prospects. Applications of precise methodologies have been reassessed with respect to the need established by recent regulatory perspectives with a fanatical and the consequent stance on prominent historical advancements and concrete purposes. An effort was also made to state an arbitrary classification of diverse design types and succinct line of application in LC and associated analyses.