1. | RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF AMOXICILLIN AND CLAVULANIC ACID IN ORAL SUSPENSION |
| D. Kalyani *, A. Elphine Prabahar, N. Ramarao |
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Article Type:Research Article
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No of Download=1093 |
Pages (93-98) |
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RP-HPLC Method was developed and subsequently validated for the determination of Amoxicillin trihydrate and Potassium clavulanate in pharmaceutical formulation. Separation was achieved with an Inertsil ODS-3 C18, 5μ, (4.6×250 mm) and phosphate buffer pH 4.3 and methanol (60:40v/v) as flow rate 1.2ml/min at 245nm. The method was validated for its Linearity, Accuracy, Precision, Robustness and Ruggedness. The linearity range was 10-60μg/ml for Amoxicillin trihydrate and 1.425-8.55μg/ml for Potassium clavulanate and the correlation coefficient for both drugs were 0.999. The accuracy was performed and the % recovery was 99.69% and 99.85% for Amoxicillin trihydrate and Potassium clavulanate respectively. Forced degradation studies were conducted on two drugs by using stress conditions such as acid stress degradation, alkali stress degradation and Peroxide stress degradation. From these studies, it was observed that the proposed acceptance criteria met the requirements for acid, alkali degradation and peroxide degradation and found to be the drugs were stable and peak purity was passed.
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2. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CILOSTAZOL IN PHARMACEUTICAL FORMULATION USING RP-HPLC |
| B.Lavanya*, A. Elphine Prabahar, N. Ramarao |
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Article Type:Research Article
Abstract
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No of Download=689 |
Pages (99-104) |
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A reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Cilostazol in Bulk and its pharmaceutical formulation. Separation was achieved with a Agilent TC-C18(2) 5μm 4.6×250mm Column using water, acetonitrile and methanol as mobile phase in a ratio of (40:50:10) v/v at flow rate 1.0 mL/min and the Column temperature was 25°C. UV detection was performed at 257 nm. The method is simple, rapid, and selective. The described method of Cilostazol is linear over a range of 15 μg/mL to 35 μg/mL. The method precision for the determination of assay was below 2.0% RSD. The % recoveries were found to be 99.7 to 101.6% for Cilostazol.
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3. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BICALUTAMIDE IN PHARMACEUTICAL FORMULATION USING RP-HPLC |
| B. Sowmya*, A. Elphine Prabahar, N. Ramarao |
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Article Type:Research Article
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No of Download=1252 |
Pages (105-110) |
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The estimation of Bicalutamide in tablets was done by Reverse Phase HPLC. The mobile phase used consists of Buffer containing sodium dihydrogen phosphate and mobile phase ratio of Sodium dihydrogen phosphate (pH 3.5) : Acetonitrile(50:50 v/v). A C18 column containing Octadecyl silane (ODS) chemically bonded to porous silica particles (250 × 4.6mm, 5μ particle size) was used as the stationary phase. The detection was carried out using UV detector set at 271nm. The solutions are chromatographed at a constant flow rate of 1.3 ml/ min. The retention time for Bicalutamide was around 9.5 min. The quantitative estimation was carried out on the tablets using RP HPLC. The quantitative results obtained are subjected to the statistical validation. The values of %RSD are less than 2.0%, indicating the accuracy and precision of the method. The percentage recoveries were found to be 99.7% to 101.6% for Bicalutamide.
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4. | FORMULATION AND EVALUATION OF FLOATING TABLETS WITH NON EFFERVESCENCE NATURAL / SYNTHETIC POLYMERS OF OSELTAMIVIR |
| M. Anvitha*, Shaik. Harun Rasheed, P. Shanmukhi |
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Article Type:Research Article
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No of Download=1094 |
Pages (111-119) |
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The present developed floating tablets with non effervescence natural/synthetic polymers of osaltamivir which were designed to prolong the gastric residence time after oral administration. Osaltamivir floating tablets were prepared by Direct Compression method incorporating natural polymer/synthetic like guar gum, HPMC, Xanthum gum, guar gum, ethyl cellulose, pvp, MCC, Magnesium sterate with sodium bicarbonate as gas generating agent and were evaluated for physico-chemical parameters i.e; drug content, swelling index, dissolution studies. All the formulations showed compliance with pharmacopeia standards. Based on the evaluation results,F5 formulations were selected as the best formulations and were checked for stability as per ICH guidelines. These results indicated that the selected formulations were stable. The drug release of optimized formulation follows the Higuchi kinetic model, and the mechanism is found to be non-Fickian/anomalous according to Korsmeyer–Peppas equation.
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5. | FORMULATION AND EVALUATION OF CONTROLLED RELEASE MATRIX TABLETS OF LOCASAMIDE |
| M.V. Phanideep*, Shaik.Harun Rasheed, P.Shanmukhi |
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Article Type:Research Article
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No of Download=685 |
Pages (120-127) |
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Epilepsy is the most common neurological disorder results in excessive electrical activity in part or all of the brain resulting in recurrent seizures. Lacosamide (LCM) is a new antiepileptic drug approved by US-FDA for the treatment of partial onset seizures. It acts in a new way that it has two novel mechanisms of action which differs from other existing anti epileptic drugs. Lacosamide has less severe side effects and less drug interactions with other drugs. HPMC, pvp, Hypromellose, PEG 6000,MCC,Lacosamide, Magnesium sterate, Talc, and were evaluated for physico-chemical parameters i.e; drug content, swelling index, dissolution studies. All the formulations showed compliance with pharmacopeia standards. Based on the evaluation results,F3 formulations were selected as the best formulations and were checked for stability as per ICH guidelines. These results indicated that the selected formulations were stable. The drug release of optimized formulation follows the Higuchi kinetic model, and the mechanism is found to be non-Fickian/anomalous according to Korsmeyer–Peppas equation.
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6. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GEMCITABINE IN PHARMACEUTICAL FORMULATION USING RP-HPLC |
| K. Kamal Joselyn*, A. Elphine Prabahar, N. Ramarao |
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Article Type:Review Article
Abstract
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No of Download=884 |
Pages (128-132) |
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The scope and objective of the present work is to optimize condition to develop estimation of Gemcitabine by HPLC method. For HPLC method, Acetonotirle and Water (50:50) was used as mobile phase which gives good resolution and good peak shapes for Gemcitabine. The flow rate was set at 1.0 mL/min, and the detection was carried out with UV detector at 270 nm. The correlation coefficient of Gemcitabine was found to be 0.9992. The developed method was validated for specificity, accuracy, precision, recovery, linearity, robustness, ruggedness and system suitability. The percentage of recovery of Gemcitabine was found to be 99.5% to 101.4% level. The low standard deviation values and good recoveries indicate the reproducibility and accuracy of the developed method. As well the % RSD values for precision study also were within acceptable limit.
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7. | METHOD DEVELOPMENT AND VALIDATION OF GEFITINIB IN BULK AND DOSAGE FORMS BY HPLC |
| B.V. Shilpa*, P.V. Suresh, N. Ramarao. |
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Article Type:Research Article
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No of Download=753 |
Pages (133-137) |
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The aim of the present work was to develop and validate a simple, efficient, economical method for the estimation of Gefitinib in bulk and dosage forms by high pressure liquid chromatography. Chromatography was performed on with Agilent TC-C18 (2) 5 ïm 4.6ï‚´250 mm, mobile phase containing Mobile phase – Acetonitrile, Methanol and Tetrahydrofuran (20:70:10) at a flow rate of 1 mL/min and eluents were monitored at 249 nm. The retention time of Gefitinib was 10.00 min showed a good linearity in the concentration range of 0.5-2.5 μg/mL for Gefitinib with a correlation coefficient of 0.997. The validation characteristics included specificity, linearity, and limit of detection, limit of quantification, precision, robustness and stability. The percent recoveries ranged between 85-115%, RSD < 2%. The method could be successfully used for the analysis of Gefitinib in bulk and dosage forms.
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8. | PHYSICO CHEMICAL CHARACTERIZATION OF INSULINS |
| Tejaswi. V*, Rajeswari. T, Pradeep. CH, Rajini Kanth. K.N, Ramarao. N. |
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Article Type:Research Article
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No of Download=870 |
Pages (138-142) |
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The aim of the present work was to develop a physiologically accurate profile of insulin absorption and drug action. Early insulin research methods for its extraction in the purest possible form from animal pancreas tissue and on methods for its large-scale production. The physicochemical characterization of insulin then followed over the subsequent two-and-a-half decades. Milestones included the crystallization of insulin the determination of its molecular weight and the demonstration that it consisted of a pair of disulfide-linked polypeptide chains, namely the acidic chain A and the basic chain B, illustrated that insulin crystals diffracted X rays, deducing at the same time the likely dimensions of the insulin molecule. The introduction of recombinant DNA technologies has allowed the development of insulin analogs, which, through their more physiologic pharmacokinetic profiles, have revolutionized insulin therapy. By using the physicochemical characterization of insulins we will determine its onset of action, duration of action, storage conditions. Among the different analogues produces by insulin we can determine which are rapid acting, long acting, intermediate acting analogues of insulin. Variations in physical activity also modify the glycemic effects of a particular dose of insulin. However, the greatest sources of variation in insulin action are frequently the differences in the physicochemical properties of insulin that affect its diffusion and its absorption in the subcutaneous tissue
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9. | METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE IN OPHTHALMIC SOLUTION BY RP-HPLC |
| Pradeep. CH*, Deepthi. B, Aaditya. M, Suresh .P.V, Ramarao. N |
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Article Type:Research Article
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No of Download=609 |
Pages (143-147) |
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Aim of the study is to develop and validate RP-HPLC method for the determination of Dorzolamide HCl and Timolol Maleate in ophthalmic solution. Separation of the drug was achieved on a INERTSIL ODS 3V 150x4.5 column using a mobile phase consisting of buffer and methanol in the ratio of 50:50v/v adjusted pH of 7.5. The flow rate was 1.0 mL/min and the detection wavelength was 276 nm. The linearity was observed in the range of 20-100 ppm for Dorzolamide and 5- ppm for Timolol with a correlation coefficient of 0.999 and 0.999 respectively. The proposed method was validated for its linearity, accuracy, precision and robustness. The low values of % R.S.D indicate the method is precise and accurate. The mean recoveries were found in the range of 99.0 – 99.9 %.
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10. | FORMULATION AND EVALUATION OF METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS |
| Dileepkumar. G*, Sanith. K |
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Article Type:Research Article
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No of Download=926 |
Pages (148-153) |
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The aim of the study is to formulate extended release tablets of Metformin HCL by employing different polymers like hydroxy propyl methyl cellulose K15M, hydroxy propyl methyl cellulose K100M and sodium carboxy methyl cellulose in different concentrations. A total of 12 formulations were prepared and studied for pre compression parameters like sieve analysis, bulk density, tapped density, angle of repose, compressibility index, Hausner’s Ratio and post compression parameters like weight variation, thickness, hardness, friability, drug content, in vitro drug release, comparative in vitro drug release study with innovator product and stability studies. Drug content in different formulations was estimated by UV spectrophotometric method. The standard deviations among the three values were found to be small. That indicates the drug was distributed almost uniformly throughout in all the formulations. The in vitro release of metformin HCL was slow and extended over longer period of time. In formulations F1-F8, the drug release was not found to be within the limit as per USP. But formulations F9-F12 showed drug release as per USP limit. Metformin HCL containing HPMC K100M and sodium CMC (H) as rate controlling polymer demonstrated slow release when compared with other formulations. The best formulation F9 compared with marketed sustained release tablet (glucophage) showed similar release profiles.
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11. | MICROBIOLOGICAL STUDY ON THE EXTRACTS OF THE ASCIDIAN EUDISTOMA VIRIDE |
| Thameemul Ansari, V. Suba |
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Article Type:Research Article
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No of Download=791 |
Pages (154-157) |
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Ascidians have some pronounced bioactive agents which shows very useful in the field of antimicrobial theraphy. In the present study methanol, dichloromethane, chloroform and hydroalcohol extracts from the ascidian Eudistoma viride were tested against various gram positive and gram negative microbial species. The methanolic extract of Eudistoma viride showed maximum activity against Staphylococcus aureus, Escherichia coli & Salmonella typhi and their zone of inhibition, respectively (13± 1.24, 12 ± 1.13 & 11 ± 0.92). The dichloromethane extract of Eudistoma viride showed maximum activity against Bacillus subtilis & Staphylococcus aureus, zone of inhibition (9.5 ± 0.67). The MIC values of the methanolic extracts of Eudistoma viride reported very low when compared with the other crude extracts.This result suggest that the antibacterial activity shown by Eudistoma viride was concentration dependent and can be used as effective inhibitor in the field of life science.
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