DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR THE ANALYSIS OF TOLPERISONE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

A simple, sensitive, rapid and precise high performance thin layer chromatographic method has been developed and validated for the estimation of Tolperisone hydrochloride in bulk and pharmaceutical dosage form. The stationary phase used was silica gel precoated aluminum plate 60F254 plates. The mobile phase used was a mixture of chloroform:acetone:toluene (6:2:2, v/v/v). The detection of spots was carried out at 265 nm. The method was validated in terms of specificity, linearity, precision and accuracy. The calibration curve was found to be linear between 50-600 ng/band. The developed method was subjected for forced degradation studies like acid, alkali, peroxide and thermal stress conditions were performed as per ICH guidelines. The proposed method was suitable for routine quality control analysis of Tolperisone hydrochloride in bulk and pharmaceutical formulation

DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND ERTUGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Objective: The present study deals with the development, validation, and application of simple, precise, and accurate high-performance liquid chromatography (HPLC) method for the simultaneous estimation of metformin hydrochloride and ertugliflozin in pharmaceutical formulation and to validate.Methods: The analytical conditions were optimized on BDS C8 column (150 mm × 4.6 mm, 5 μm) at room temperature. The mobile phase consists of buffer: acetonitrile in 55:45 v/v ratio. Injection volume was 10 μl. The flow rate was maintained at 1.0 ml/min, and the analysis was carried out at 224 nm.Results: The method was found to be linear in the concentration range of 125–750 μg/ml and 1.875–11.25 μg/ml for metformin hydrochloride and ertugliflozin with regression coefficient r2 = 0.999. The method was found to be precise with percentage relative standard deviation below 2%. The limit of detection and limit of quantification were found to be within the limits. The percentage recovery of the developed method was 100.15%. All the validation parameters such as robustness, recovery, and precision were found to be within the limits. Degradation parameters such as acid, base, thermal and peroxide, light, temperature, and humidity were performed and found that the drugs are stable in all the extreme conditions.Conclusions: A simple, accurate, precise, and less time-consuming reversed-phase HPLC method for the simultaneous estimation of metformin hydrochloride and ertugliflozin has been developed and validated in accordance with the ICH guidelines

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND GLIPIZIDE

A novel, precise and accurate stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Metformin and Glipizide in combined pharmaceutical dosage form. Chromatographic separation was achieved on Microsorb-MV C18 column (250 × 4.6 mm, 5 μm) with UV detection at 257 nm. The mobile phase consists of acetate buffer (pH 4.0) and acetonitrile in the ratio of 60:40 v/v and at a flow rate of 1.0 mL/min. The method was linear over the concentration range of 60-140 μg/mL for Metformin and 10-50 μg/mL for Glipizide. The retention times for Metformin and Glipizide were found to be 2.434 min and 5.710 min respectively. The mean percentage recoveries of Metformin and Glipizide were found to be 100.42% and 100.39% respectively. The method was validated and was successfully employed for the routine quantitative analysis of pharmaceutical formulations containing Metformin and Glipizide in combined pharmaceutical formulation

A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION RIBAVIRIN IN TABLETS

Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Ribavirin (200mg) in tablets.Methods: The optimized method uses a reverse phase column, Enable Make KromasilC18 (250 X 4.6 mm; 5μ), a mobile phase of phosphate buffer (pH 4.2): acetonitrile in the proportion of 85:15 v/v, flow rate of 1.0 ml/min and a detection wavelength of 215 nm using a PDA detector.Results: The developed method resulted in Ribavirin eluting at 2.606 min. Ribavirin exhibited linear in the range 25-150μg/ml. The precision is exemplified by the relative standard deviation of 0.4%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 0.24ng/ml and 0.73ng/ml respectively.Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Ribavirin in VIRAZIDE (200mg) tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.Â

Antibacterial and analgesic activity of leaves of Lantana camara

The leaves of the plant Lantana camara were extracted with different solvents and screened for their antibacterial and analgesic activities. The chloroform and methanolic extract of the plant Lantana camara has showed the presence of four alkaloid compounds each. Antibacterial activity was evaluated using MIC method against bacteria. The analgesic activity of different extracts of Lantana camara leaves is evaluated by Eddy’s hot plate method where the responses are jumping withdrawal of paws and licking of paws. This study demonstrates that leaf powder of Lantana camara has significant antibacterial and analgesic activities

FORMULATION AND IN VITRO EVALUATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN BILAYERED TABLETS

Dapagliflozin (DG) is a sodium glucose cotransporter-2 (SGLT-2) inhibitor and Saxagliptin (SG) is a dipeptidyl peptidase-4 (DPP-4) inhibitor. The aim of the present work is to formulate a bilayered tablet (BT) of DG as immediate release (IR) layer and SG as sustained release (SR) layer by direct compression method for the effective treatment of type 2 diabetes mellitus. Type and concentration of superdisintegrant among [sodium starch glycolate (SSG)/Lycoat RS720/ Ludiflash] was optimized to enhance the dissolution rate (DR) of DG from the IR layer of BT. Type and concentration of SR polymer among (Carbapol 940/ Karaya gum/ HPMC K15M) was optimized to extend the release of SG up to 12 h with zero order release profile from the SR layer of BT. It was concluded that the optimization of the ratio of SG: SR polymer (HPMC K15M), had significant effect on extending the release profiles of SG. The ratio of SG: HPMC K15M at 1:18 respectively forms a better matrix for the extending the release of SG up to 12 h from the SR layer of BT. The optimized formulation; BT9 [IR9 (6% w/w Ludiflash as superdisintegrant and SR9 (with 60% HPMC K15M as SR polymer)] releases 100% of DG from the IR layer with in 45 min and extends the release of SG up to 12 h with a better zero order release profile (r2=0.994). It passes the accelerated stability studies as per ICH guidelines. A combination of these two classes [SGLT-2 inhibitors (DG) and DPP-4 inhibitors (SG)] of glucose-lowering agents and formulating them as a BT is more effective in the treatment and maintenance of type 2 diabetes mellitus

Intellectual Property Rights of Electronic Information in the Age of Digital Convergence

The laws of intellectual property aim to protect owners of the literary, dramatic, musical, and artistic works; designs, innovations and inventions from unauthorized use or exploitation by some one else. Though every country has enacted laws to protect intellectual property of its citizens, many infringements take place and a majority of them end up in courts of law. The developments in information and communication technologies made the situation grimmer. This paper briefly explains the copyright and protection of electronic information, its security in network environment, and copyright provisions for databases, multimedia works, and computer software. The relevant provisions of the European Union, the American and the Indian legislative developments as well as the international efforts were touched. The various facets of the information Technology Act and the recently tabled Communications Convergence Bill have been discussed. Despite all the legislative efforts, a level playing field is needed for the rights owners, publishers, library professionals and user

HEPATOPROTECTIVE ACTIVITY OF ALSTONIA SCHOLARIS FRUITS AGAINST CARBON TETRACHLORIDE-INDUCED HEPATOTOXICITY IN RATS

The hepatoprotective activity of ethanolic extract of fruits of Alstonia scholaris was evaluated by carbon tetrachloride (CCL4)-induced hepatotoxicity in rats. The toxicant CCL4 was used to induce hepatotoxicity at a dose of 2 ml/kg as 1:1 mixture with olive oil. The ethanolic extract of fruits of Alstonia scholaris was administered in the dose of 150 and 300 mg/kg/day orally for 5 days. Silymarin (50 mg/kg) was used as standard drug. The hepatoprotective effect of the ethanolic extract was evaluated by the assessment of biochemical parameters such as SGOT, SGPT, SALKP, total bilirubin and histopathological studies of the liver. Treatment of animals with the ethanolic extract significantly reduced the liver damage and the symptoms of liver injury by restoration of architecture of liver as indicated by lower levels of serum bilirubin as compared with the normal and silymarin treated groups

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND LORNOXICAM IN BULK AND PHARMACEUTICAL DOSAGE FORM

A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for simultaneous estimation of Paracetamol and Lornoxicam in tablet dosage form. The chromatographic separation was carried out on Zorbax C18 column (150 mm x 4.6 mm I.D., 5 µm particle size) with a mixture of 20 mM ammonium acetate pH 3.2 buffer and acetonitrile in the ratio of 60:40 v/v as a mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 265 nm. The retention times were 2.74 minutes and 5.36 minutes for Paracetamol and Lornoxicam respectively. Calibration plots were linear (r2=0.999 for both Paracetamol and Lornoxicam respectively) over the concentration range of 6.25-250 µg/mL for Paracetamol and 0.1-4 µg/mL for Lornoxicam. The method was validated for linearity, precision, accuracy, ruggedness and robustness. The proposed method was successfully used for simultaneous estimation of Paracetamol and Lornoxicam in tablet dosage form. Validation studies revealed that the proposed method is specific, rapid, reliable and reproducible. The high % recovery and low % RSD confirms the suitability of the proposed method for routine quality control analysis of Paracetamol and Lornoxicam in bulk and tablet dosage form

ESTIMATION OF GATIFLOXACIN IN PHARMACEUTICAL DOSAGE FORMS BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

A simple, rapid, sensitive and preciseHigh Performance Liquid Chromatographic(HPLC) method has been developed for theestimation of gatifloxacin in its pharmaceuticaldosage forms. In this method RP-C18 column(150mmx4.6mm I.D., 5 m particle size) withmobile phase consisting of acetonitrile and 0.05Mphosphate buffer in the ratio of 25:75 v/v inisocratic mode was used. The detection wavelengthis 293nm and the flow rate is 0.8ml/min.Ciprofloxacin is used as internal standard. Thelinearity was found to be in the range of 0.1 to 10g/ml and shows a correlation coefficient of0.9999. The intra- and inter-day variation wasfound to be less than 1.2% showing high precisionof the assay method. The mean percent recovery ofthe drug from the solution containing 4 g/ml was100.5 2.06 indicating high accuracy of theproposed method. Hence, this method is simple,fast, specific, accurate, precise and less timeconsuming for the estimation of gatifloxacin inpharmaceutical dosage form