Standardisation is a process by which it is confirm that products are true beyond any doubt in respect of quality, efficacy, performance and safety. Importance of standard0ization is its chemical values of the individual drugs in the finished products can be used as preliminary reference standards for market samples of the single drugs. Awareness and general acceptability of the use of herbal drugs in today’s medical practice become greater in size worldwide. For the standardization, the extracts are subjected to chemical test, physical studies (ash and extractive values, pH, reducing sugar, alcohol content and etc.) and chromatographically studies (TLC, HPTLC and HPLC etc.). Heavy metal contamination also determined in the formulation by atomic absorption spectrometer (AAS). Stakeholders in herbal medicine require establishing quality parameters for collection, handling, processing and production of herbal medicine and parallel employing such parameters to make certain the safety of the global herbal market. The processes of good quality assurance and standardization of herbal medicines and products were also discussed. To achieve the authentic herbal drug chromatography is one of the key factors for that. Herbal formulations have reached extensive acceptability as therapeutic agents for several diseases we hope our research findings will help the Ayurveda industry for formulating/marketing standard drug with international acceptance.

The developed method was a simple, efficient, economical method for the Validation of Finasteride Impurities in Pure and Drug product by reverse phase high pressure liquid chromatography. For Finasteride Impurities Chromatography was performed on Waters Nova-Pak, C18, 250 × 4.6µ with mobile phase Water: Tetra hydro furan: ACN at a flow rate of 1.8 mL/min and eluents were monitored at 210 nm The retention times of Impurity - A, Impurity - B, Impurity - C and Impurity - D are 32.80, 40.86, 46.50 and 38.349 respectively and showed a good linearity in the concentration range of 15 - 300 µg/ml for all Impurities with a correlation coefficient of 0.999, 0.999, 0.999 and 0.999 respectively. The percent recoveries ranged between 92.1-108.2%. RSD for all Parameters are within the acceptance. The method could be successfully used for the analysis Impurities of Finasteride.

1, 5 benzothaizepines heterocyclic ring system having the diverse pharmacological activities. The present work focus on synthesis of novel benzothaizepines molecules by condensation of 1-(2', 4'-difluorophenyl)-3-(4"-methylphenyl)-2-propen-1-one derivatives and O-amino thiophenol in the presence piperidine and glacial acetic acid. The structures of compounds were confirmed by spectral analysis using IR, 1HNMR and Mass analysis. The biological evolution of compounds was performed for anti-microbial activity by using serial dilution method and cytotoxicity studies by MTT assay method.

The Purpose of this work to develop an accurate, simple, sensitive and precise RP-HPLC method was developed for the determination of Dutasteride and Tamsulosin hydrochloride in tablet dosage form. The RP-HPLC separation was achieved on BDS Hypersil C18 column (250 mm, id 4.6 mm, 5 μm) using mobile phase CH3COONH4: Methanol (550:450)v/v) at a flow rate of 0.8 ml/min at an 30 0C temperature. Quantification was achieved with photodiode array detection at 254 nm over the concentration range 80μg/ml. The propose method was validated for its linearity. Statistically, accuracy, precision and robustness. This method can be employed for routine quality control analysis of Dutasteride and Tamsulosin Hydrochloride in tablet dosage form, and also applied successfully for the determination of dutasteride and Tamsulosin Hydrochloride in combination of pharmaceutical dosage form.

The developed method was a simple, efficient, economical method for the Validation of Tolvaptan and its related substances in Drug product by RP- HPLC. In this method Inertsil ODS-3V column (250×4.6mm, 5μm) as column. All the parameters used in this method were validated in compliance with the regulatory guidelines by using well developed Analytical method validation tool. Parameters are like Linearity, Specificity, Accuracy, System suitability, Robustness, Ruggedness and Method precision. The results obtained were well within the acceptance criteria.