INTRODUCTION Pharmaceutical analysis is a measurement science consisting of a set of powerful ideas and methods that are useful in all fields of science and medicine. Both quantitative and qualitative information‟s are required in an analysis. Qualitative analysis establishes the chemical identity of a species in a sample and quantitative analysis establishes the chemical identity of a species in a sample and quantitative analysis determines the relative amount of these species or analytes, in numerical terms. Analytical methods are applied throughout pharmaceutical industry for their daily working. Pharmaceutical analysis determines the quality of drug product via analytical chemistry that involves a series of process for identification, determination, quantification, and purification of a substance, separation of the components of a solution or mixture or determination of structure of chemical compounds. These teqniques are based on the various phytochemical properties of the compounds of interest The quantitative analysis can be performed by various instrumental and chemical methods of analysis. Chemical methods of analysis executes various chemical reactions for quantitative analytical measurement include gravimetric ,titrimetric and volumetric method of analysis but accuracy speed and reproducibility are limited Instrumental method involves measurement of some or physical properties of the compound or substance. Instrumental to methods are proffered due to their selectivity, high speed, accuracy and simplicity of analysis. These methods are employed for determination of minor or trace concentration of element in the sample any change in the properties of the system are detected by measurement of absorbance, specific rotation, refractive index, migration difference, charge to mass ratio etc… The selection of the analytical methods is in turn determined by the purpose and objective of the investigation. In general, analytical method is selected according to the analyte and matrix in the determined sample in order to ensure the accuracy and reliability of the analytical result. Traditional medicine is a broad term encompassing health practices, approaches, knowledge and beliefs which incorporate herbal, animal and mineral based medicines, spiritual therapies, manual techniques and exercises, applied singularly or in combination to treat, diagnose and prevent illnesses or maintain well-being. Natural medicines provide valuable resources to meet the requirements for global health care at affordable prices. Therefore, safety and efficacy need to be proven in a comparable manner to conventional drugs. Evidence-based natural and western medicine may merge to a “one-world medicine” for the sake of all patients in industrialized and developing countries. In the present review, we discuss strategies for preservation of traditional knowledge on natural medicines, sustainability of medicinal herbs and natural products, and standardization and quality control. The objective of this study was to examine the methods used in systematic reviews of safety across a range of complementary therapies to assess the variation in approach and the potential for developing guidance on conduct and reporting. Herbal medicine, or phototherapy, is the science of using herbal remedies to treat the sick. It therefore covers everything from medicinal plants with powerful actions; the term phototherapy was introduced by the French physician Henri Leclerc (1870-1955). Herbal medicine has come a long way since the days of the ancient „herbalism‟. The study of the use of medicinal plants is now a scientific subject, a field of medicine in the same way as chemotherapy, hydrotherapy, electrotherapy and others. Knowledge of medicinal plants and their uses has been recorded from antiquity. IMPORTANCE OF HERBAL MEDICINE The points of thought are the common people divert to use the Ayurvedic, Chinese and other herbal medicines because it is used all over the world, in India, its use is much more because of their easy accessibility, no expert consultation required, are considered safe to use and also because primary health care services fall short of peoples‟ need both in qualitative and quantitative terms. We should make all these easily marketed ayurvedic, and other herbal medicines FDA approved and increase public awareness about pros and cons of their uses. The common belief that anything natural is safe is not correct. Herbal Medicines are readily available in the market from health food stores without prescriptions and are widely used in India, China, and USA and all over the world. According to recent survey the majority of people who use herbal medicines do not inform their physicians about their consumptions that can cause abnormal test results and confusion in proper diagnosis. However, natural medicines seem to be barely able to provide convincing alternatives to conventional western medicine for global health-care. Some reasons are 1) The knowledge of shamans and traditional healers is getting lost, since their oral traditions being handed down from generation to generation for thousands of years seem to be extinguished in modern times. 2) The traditional use of medicinal plants needs to be systematically investigated and standardized. People outside the field of phytotherapy that phytotherapy is inactive, because infectious diseases would otherwise not kill many millions of patients each year, which is striking and embarrassing at the same time for scientists working on natural medicines. 3) The rainforests and other biological habitats are getting extinguished with a breath-taking velocity. Half of the rainforest worldwide has already been destroyed during the past three decades. This has irreversible impact on drug development 4) Overharvesting of medicinal plants from the wild presents a severe problem of preserving many plant species endangered to be extinguished. 5) Global climate change may affect both the growths of medicinal plants as well as their constituents. STANDARDISATION OF HERBAL FORMULATION pharmacognostic evaluation chemical parameters standerdisation of herbal formulations chromatographic and spectroscopic analysis microbial parameters physico chemical parameters Quality Control of Herbal Drugs Quality control for efficacy and safety of herbal products is of paramount importance. Quality can be defined as the status of a drug that is determined by identity, purity, content, and other chemical, physical, or biological properties, or by the manufacturing processes. Quality control is a term that refers to processes involved in maintaining the quality and validity of a manufactured product. The term “herbal drugs” denotes plants or plant parts that have been converted into phytopharmaceuticals by means of simple processes involving harvesting, drying, and storage [3]. Hence they are capable of variation. This variability is also caused by differences in growth, geographical location, and time of harvesting. A practical addition to the definition is also to include other crude products derived from plants, which no longer show any organic structure, such as essential oils, fatty oils, resins, and gums. Derived or isolated compounds (e.g. strychnine from strychnous nux-vomica) or mixtures of compounds (e.g. abrin from Abrus precatorius). In general, quality control is based on three important pharmacopeial definitions - it should have one herb – it should not have any contaminant other than herb -the active constituents should be within the defined limits. It is obvious that the content is the most difficult one to assess, since in most herbal drugs the active constituents are unknown. Sometimes markers can be used which are, by definition, chemically defined constituents that are of interest for control purposes, independent of whether they have any therapeutic activity or not . Identity can be achieved by macro and microscopical examinations. Voucher specimens are reliable reference sources. Outbreaks of diseases among plants may result in changes to the physical appearance of the plant and lead to incorrect identification [5,6]. At times an incorrect botanical quality with respect to the labeling can be a problem. Purity is closely linked with safe use of drugs and deals with factors such as ash values, contaminants (e.g. foreign matter in the form of other herbs), and heavy metals. However, due to the application of improved analytical methods, modern purity evaluation also includes microbial contamination, aflatoxins, radioactivity, and pesticide residues. Analytical methods such as photometric analysis, Thin layer chromatography (TLC), High performance liquid chromatography (HPLC), High performance thin layer chromatography (HPTLC), and Gas chromatography (GC) can be employed in order to establish the constant composition of herbal preparations. Content or assay is the most difficult area of quality control to perform, since in most herbal drugs the active constituents are unknown. Sometimes markers can be used. In all other cases, where no active constituents or marker can be defined for the herbal drug, the percentage extractable matter with a solvent may be used as a form of assay, an approach often seen in pharmacopeia. A special form of assay is the determination of essential oils by steam distillation. When active constituents (e.g. sennosides in senna) or markers (e.g. alkydamides in Echinacea) are known, a vast array of modern chemical analytical methods such as ultraviolet/visible spectroscopy(UV/VIS), TLC,HPLC, HPTLC, GC, mass spectrometry, or a combination of GC and MS(GC/MS), can be employed. Techniques in Herbal Drug Identification and Characterization 1. HPLC Preparative and analytical HPLC are widely used in pharmaceutical industry for isolating and purification of herbal compounds. There are basically two types of preparative HPLC: low pressure HPLC (typically under 5 bar) and high pressure HPLC (pressure >20 bar). The important parameters to be considered are resolution, sensitivity and fast analysis time in analytical HPLC whereas both the degree of solute purity as well as the amount of compound that can be produced per unit time i.e. throughput or recovery in preparative HPLC. Vasicine, the major bioactive alkaloid of Adhatoda vusica, was estimated by HPLC in two polyherbal drug formulations - Shereeshadi Kashaya and Yastyadivati, Standardization of the Triphala (an antioxidant-rich herbal formulation) mixture of Emblica officinalis, Terminalia chebula and T. belerica in equal proportions has been reported by the HPLC method by using the RP18 column with an acidic mobile phase. 2. Liquid chromatography- massspectroscopy (LCMS) LC-MS has become method of choice in many stages of drug development. Chemical standardization of an aqueous extract of the mixture of the 20 herbs provided 20 chemical compounds serving as reference markers using LC-MS Further, LC-MS analysis of aminoglycosides showed that these drugs are highly soluble in water, exhibited low plasma protein binding, and were more than 90% excreted through the kidney. Further this technique helps in analysis of aminoglycosides in plasma samples with ion pairing chromatography. Two HPLC methods, one combined with a photodiode array detector (LC/UV) and another with mass spectrometry (LC/MS), were reported for the analysis of aristolochic acid I and II in herbal medicines. 3. Gas chromatography (GC) and gas chromatography-mass spectroscopy (GC-MS) GC-MS instruments have been used for identification of large number of components present in natural and biological systems. The identification and quantification of chemical constituents present in polyherbal oil formulation (Megni) consisting of nine ingredients, mainly Myristica fragrans, Eucalyptus globulus, Gaultheria procumbens and Mentha piperita was analyzed by GCMS method. 4. Supercritical fluid chromatography (SFC) Supercritical fluid chromatography is a hybrid of gas and liquid chromatography. This technique is an important third kind of column chromatography that is beginning to find use in many industrial, regulatory, and academic laboratories. supercritical fluid chromatography is of importance because it permits the separation and determination of a group of compounds that are not conveniently handled by either gas or little chromatography. 5. Capillary electrophoresis (CE) Researchers evaluated the importance of CE for quality control of herbal medicinal products. Several CE studies dealing with herbal medicines have been reported and two kinds of medicinal compound i.e. alkaloids and flavonoids have been studied extensively. The methodology of CE was established to evaluate one herb drug in terms of specificity, sensitivity and precision, and the results were in agreement with those obtained by the HPLC method. 6. Thermal analysis of herbal drugs Thermo gravimetric analysis (TGA), differential thermal analysis (DTA) and differential scanning calorimetry (DSC) have been employed to study any physical or chemical changes in various products including herbal drugs and also used to study preformulation or drug excipient compatibility. TGA may be operated under subambient conditions to analyse ethanol in herbal formulations such as asavas and arista. TGA and DTA analysis of mercury based Indian traditional metallic herbal drug Ras-sindoor indicated the presence of mercury sulphide based on a sharp peak at 354o C which corresponded to melting temperature of mercury sulphide. 7. X-ray powder diffractometry (X-RPD) This technique is used to identify minerals, crystalline materials and metallic based herbal formulations. The tin based herbal drug Vanga Parpam was estimated by XRD and the intense sharp diffraction peaks clearly confirmed the presence of high crystallinity in Vanga Parpam. XRD analysis of metallic based Indian traditionally medicine Ras-sindoor indicated the presence of mercury sulphide which is represented by sharp peak. X-ray powder diffractometry data confirmed the formation of phospholipid complex with emodin, naringenin , quercetin, Gallic acid. 8. Infrared spectroscopy FTIR along with the statistical method principal component analysis (PCA) was applied to identify and discriminate herbal medicines for quality control in the fingerprint region 400-2000 cm-1. The ratio of the areas of any two marked characteristic peaks was found to be nearly consistent for the same plant from different regions, thereby, an additional discrimination method for herbal medicines. PCA clusters herbal medicines into different groups, clearly showing that IR method can adequately discriminate different herbal medicines using FTIR data. Near-infrared spectroscopy technique has been used for rapid determination of active components, species, geographic origin, special medicinal formula, on-line quality control, identification of counterfeit and discrimination of geographical origins of Chinese herbal medicines. 9. High performance thin layer chromatography (HPTLC) Among the modern Analytical tools HPTLC is a powerful analytical method equally suitable for qualitative and quantitative analytical tasks. HPTLC is playing an important role in today analytical world, not in competition to HPLC but as a complementary method. One of the most obvious orthogonal features of the two techniques is the primary use of reversed phases in HPLC versus unmodified silica gel in HPTLC, resulting in partition chromatography and adsorption chromatography respectively. Unlike other methods, HPTLC produces visible chromatograms complex information about the entire sample is available at a glance. Multiple samples are seen simultaneously, So that reference and test samples can be compared for identification. Similarities and differences are immediately apparent and with the help of the image comparison. Several chromatograms can be compared directly, even from different plates. In addition to the visible chromatograms, analog peak data are also available from the chromatogram. They can be evaluated either by the image based software Videoscan or by scanning densitometry with TLC Scanner, measuring the absorption and/or fluorescence of the substances on the plate. TLC is an offline technique: the subsequent steps are relatively independent, allowing parallel treatment of multiple samples during chromatography, derivatization and detection. Some of the steps can be repeated independently of others, for example in post chromatographic derivatization, some reagents can be applied in sequence allowing multiple derivatization and thus multiple detection of the same sample. In view of the above article describes the key features of traditional thin layer chromatography and modern HPTLC advantages. Key feature of HPTLC 1. Simultaneous processing of sample and standard - better analytical precision and accuracy less need for Internal Standard. 2. Several analysts work simultaneously. 3. Lower analysis time and less cost per analysis. 4. Low maintenance cost. 5. Simple sample preparation - handle samples of divergent nature. 6. No prior treatment for solvents like filtration and degassing. 7. Low mobile phase consumption per sample 8. No interference from previous analysis – fresh stationary and mobile phases for each analysis - no contamination. 9. Visual detection possible - open system. HPTLC- High Performance Thin Layer Chromatography is a sophisticated and automated form of TLC.Main Difference of HPTLC and TLC Particle and Pore size of Sorbents. HPTLC TLC Layer of sorbent Efficiency Separations Analysis Time particle size generated - 5 cm - 15 cm distance and the analysis time is greatly reduced Solid support stationary phases like Alumina & silica gel for normal Kiesulguhr phase and C8 , C18 for reversed phase modes Development chamber less amount of mobile phase Sample spotting Scanning Fluorescence scanner scans the entire chromatogram qualitatively and quantitatively and the scanner is an advanced type of densitometer Steps involved in HPTLC : Selection of chromatographic layer Sample and Standard Preparation Activation of pre-coated plates Application of sample and standard Selection of mobile phase Pre- conditioning (Chamber saturation) Chromatographic development and drying Detection and visualization Quantification Documentation Multiple Detection Scanning densitometry