Quality Evaluation of Generic Products of Metformin and Vildagliptin Tablets

The aim of the present study was the evaluation and comparison between four different Metformin and Vildagliptin tablets which are commercially available in Indian market. These tablets were assessed for various pharmacopoeial quality control tests. Parameters including weight variation, hardness, friability, drug content, and disintegration time were evaluated. Results were within acceptable limits for all selected products (three generic and an innovator). These results show that the tested generic products were biopharmaceutically similar to the innovator formulation. Therefore, the consumer can select any one of these equivalent products as a substitute for innovator product in case of cost concern or unavailability.

Bioanalysis - Method Development, Validation, Sample Preparation, its Detection Techniques and its Application

Quantitatively measurements of chemical and biological drugs and their metabolites in the biological sample. This used in clinical and non-clinical studies. Non clinical including Pharmacokinetic and Toxic kinetic study, and clinical including Bioavailability, Bioequivalence study. This are play significant role and help in improvement in technology and analytical methods. Recent years have witnessed the introduction of several high- quality review articles into the literature covering various scientific and technical aspects of bioanalysis. Method validation and development use for the purpose of suitability of method for their intended purpose, this are important in Drug Discovery and Development. It including a validation parameters are Accuracy, Precision, Range, Calibration Curve, Recovery, Limit of Detection, Limit of Quantitation, Specificity, Selectivity and Stability, Ruggedness. This applicable in bio analysis, FDA and EMA guidelines. There are 3 main Extraction techniques used in sample preparation in bioanalysis is precipitation, liquid –liquid extraction, solid phase extraction. Detection of analyte by using hyphenated and chromatographic techniques like LC-MS/MS, HPLC, GC-MS. This LC-MS/MS is commonly used in a bioanalysis. This bio analysis study used in Pharmaceutical, Biomedical research purpose. Many challenges in pharmaceutical industry that fulfill by the utilization of analytical technologies and high-throughput automated platforms has been employed; in order to perform more experiments in a shorter time frame with increased data quality.

Antimicrobial Activity of Synthesized Zinc Oxide Nanoparticles using Ajuga bracteosa Leaf Extract

Nanoscience and nanotechnology has attracted a lot of attention because of its wide variety of applications. Plant based metallic nanoparticles revolutionized the health sector with targeting nano drug to cure different ailments. Living beings are known to be susceptible to microbial attack followed by multidrug resistance of microorganism put the necessitates for searching more efficient methods of drug delivery or drug production. In the present study, we report the green synthesis of stable hexagonally shaped zinc oxide nanoparticles from leaf extract of Ajuga bracteosa and their antimicrobial efficacy against the selected bacterial (Streptococcus pneumonia, Staphylococcus aureus, Klebsiella pneumonia, Escherichia coli and Pseudomonas aeruginosa) and fungal (Aspergillus fumigates and Trichoderma viride) strains by using agar well diffusion method. Initial colour change and surface-plasmon-resonance (SPR) absorbance bands between 349 nm gave support to the synthesis of zinc oxide nanoparticles. These nanoparticles were further characterized by XRD, EDX, TEM and FTIR techniques. XRD analysis showed that nanoparticles are crystalline in nature. TEM measurements showed that nanoparticles are hexagonally shaped with their average size less than 27 nm. FTIR spectra confirms the presence of phytochemicals which were responsible for reducing, capping and stabilizing the nanoparticles. Antimicrobial results of the synthesized ZnO nanoparticles has indicated the good potential of nanoparticles against all tested microorganism in the present study.

Degradation Profiling of Lisinopril and Hydrochlorothiazide by RP- HPLC method with QbD Approach

RP-HPLC method was developed for the estimation of Lisinopril and Hydrochlorothiazide in tablet dosage form with the help of Quality by Design (QbD) approaches. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 226.0 nm and solving the equation. The RP-HPLC method was performed C18-(100mm x 4.6 mm,)2.5 μm particle size in gradient mode, and the sample was analysed using methanol 45.0 ml and 55.0 ml (pH 3.3 0.05% OPA with TEA) as a mobile phase at a flow rate of 0.8 ml/min and detection at nm. By the retention time for Lisinopril and Hydrochlorothiazide found 3.39 and 4.59 min respectively. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 5-25 and 12.5-62.5 μg/ml for Lisinopril and Hydrochlorothiazide respectively, and recoveries from tablet dosage form were between 99.02 and 100.00 %. The method can be used for routine of the quality control in pharmaceuticals. The degradation profiling of Lisinopril and Hydrochlorothiazide were also carried out.

A Review on GC-MS Hyphenated Technique

The hyphenated technique is developed from the coupling of a separation technique and an on-line spectroscopic detection technology, GCMS, LC-MS, LC-FTIR, LC-NMR, and CE-MS. Gas chromatography combined with mass spectrometry is an important technique for identification and quantification of analytes in multifactor systems. GC-MS is highly effective and versatile analytical techniques with numerous scientific applications to cater the field of applied Sciences and Technology. This review elaborates the significant uses of this technique. It includes a brief discussion of the instrumental set-up and theory for the comprehensive GC × GC hyphenated with different detection techniques. It is fast and sensitive, provides a high peak capacity, and allows determination of thermally stable and volatile compounds.

Two Dimensional Gas Chromatography- A Review

The birth of two-dimensional gas chromatography is assumed to be the ninetieth year of the last century. Two-dimensional gas chromatography is a rapidly developing analytical technique. GCxGC is a truly hyphenated chromatographic technique which employs a pair of GC column. GCxGC analyses, such as the identification of trace compounds that would not be perceived by 1D-GC. The use of 2D-GC compared to that of 1D-GC has been discussed. The paper presents the introduction, principle of operation, working, uses, application, case studies has been discussed.

Method Development and Validation for the Estimation of Etizolam and Propranolol Hydrochloride in bulk and Combined Dosage Forms by Simultaneous and Derivative Spectroscopic Methods

Accurate, simple, sensitive and rapid economic UV spectroscopic methods were developed for the estimation of Etizolam and Propranolol Hydrochloride in bulk and combined dosage form. The present study deals with the UV spectroscopic method development and validation for the Simultaneous Equation method and First Derivative method of Etizolam and Propranolol Hydrochloride in bulk and combined dosage form at determined wavelength of Etizolam and Propranolol Hydrochloride at 244nm and 288nm for Simultaneous Equation method and 234nm and 289nm for First Derivative Method. The linearity range for Etizolam and Propranolol Hydrochloride was 1-5µg/ml and 10-50µg/ml, and exhibit good correlation coefficient of Etizolam and Propranolol Hydrochloride was 0.9877 and 0.9977 for Simultaneous Equation method and 0.9872 and 0.9977 for First Derivative method, respectively and excellent mean recovery (98-102%). The precision was found to be within limit (%RSD <2). Comparatively First Derivative method is more sensitive than Simultaneous Equation method. The methods were validated statistically and parameters like linearity, precision, accuracy, specificity and assay was studied according to ICH guidelines and can be applicable in determination of both drugs in routine quality control analysis of drugs in bulk and combined dosage form.

A Review on Role of Pharmacist in Current Healthcare Scenrio

During the last few years, the pharmacy profession has expand significantly in terms of professional services delivery and now has been recognized as an important profession in the multidisciplinary provision of health care. The paper highlights the current scenario the Pharmacy profession in health care system. Pharmacist is a backbone that strengthens to health care system. Different roles of Pharmacist in different sectors of pharmacy profession like Industrial, academics, community health, clinical research, drug design and discovery, developing NDDS etc. In nutshell pharmacist play an integral part of health care system. “Physician gives medicine to the patients but life to medicine given by pharmacist”.

Analytical Method Validation and Quantitative Analysis for Active Pharmaceutical Ingredient and Marketed Formulation of Teneligliptin Hydrobromide by UV Spectroscopy

A Dipeptidyl peptidase-4 inhibitor teneligliptin hydrobromide is used for lowering blood glucose levels in people with diabetes mellitus. A very straight forward, quick, responsive and accurate UV- Spectrophotometric method of analysis have been developed for assessment of Teneligliptin Hydrobromide in pharmaceutical formulation. Since teneligliptin hydrobromide only absorbs UV in the low wavelength area, it cannot be identify with high sensitivity. Teneligliptin Hydrobromide has shown successful results for various analytical instruments only in the permutation of Taurine and Sodium periodate. The API was derivatives using Taurine and Sodium periodate in water and methanol. Drug exhibited distinct λmax in methanol at 281nm. Linearity was observed in the concentration range 10-80 μg/ml. The method was validated by recovery studies. The methods used are inexpensive and sensitive for the inference of teneligliptin hydrobromide in bulk drug and tablet dosage forms.

An Overview on Estimation of Lacidipine from Bulk and Formulation

Lacidipine is a calcium channel blocker used in treatment of cardiac arrhythmia. Several methods had been reported for the estimation of lacidipine from bulk and formulations. Here in this an attempt is made to summarize the different methods used along with their specifications. Every method reported for the analysis had its own advantages over the other methods. As per the industrial scalability HPLC is the most useful and effective method for the estimation of Lacidipine from bulk and formulations.