1. | METHOD DEVELOPMENT AND VALIDATION OF CHROMIUM PICOLINATE AND METFORMIN BY RP-HPLC |
| Arunamma D* and Dharmamoorthy G |
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The method is said to be sensitive if small changes in concentration cause large changes in response function. The sensitivity of an analytical method is determined from the slope of the calibration line. The limits of quantification (LOQ) or working dynamic range of bio analytical method are defined as the highest and lowest concentrations, which can determined with acceptable accuracy. It is suggested that, this be set at  15% for both the upper and lower limit of quantitation respectively. Any sample concentration that falls outside the calibration range cannot be interpolated from the calibration line and extrapolation of the calibration curve is discouraged. If the concentration is over range, the sample should be diluted in drug-free matrix and re-assayed. Keywords: Reserpine, Chromium Picolinate, RP-HPLC, Metformin, Method validation
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2. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY NEW RP-UPLC METHOD FOR THE DETERMINATION OF DOLUTEGRAVIR SODIUM IN TABLET DOSAGE FORM |
| P.V. Murali Krishna* , Rajesh Asija, M. Purushothaman |
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A simple accurate, precise rapid isocratic UPLC method development for the simultaneous estimation of Dolutegravir Sodium in tablet dosage form. The chromatographic system was carried on Acquity BEH C18 (50*3.0mm. 1.7µm) using mobile phase consisting a mixture of 70 volmes of Dipotassium hydrogen orthophosphate of 30 volumes of Methanol, with detection of 260 nm. The retention time of Dolutegravir Sodium was found to be 2.857 min calibration curve was linear over the concentration range of Dolutegravir Sodium, the correlation coefficient for both peak was found to be 0.998 respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines. Keywords: Dolutegravir Sodium, UPLC.
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3. | PREPARATION AND EVALUATION OF PULSATILE RELEASE TABLETS OF KETOPROFEN CONTAINING AC DI SOL AND SODIUM STARCH GLYCOLATE |
| M. Purushothaman*, C. SadakVali , Rajesh Asija |
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The main aim and objective of present investigation was to formulate and evaluate pulsatile tablets delivery system for Anti-inflammatory drugs like ketoprofen. Chrono modulated drug delivery systems release the drug at predetermined lag time in diseases like cardiovascular disorders, diabetes mellitus, bronchial asthma, rheumatoid arthritis, peptic ulcers. Ketoprofen is an anti-inflammatory drug used in treatment of rheumatoid arthritis. Core tablets of ketoprofen were prepared using various super disintegrants like Ac di sol and sodium starch glycolate using direct compression method. The core tablets were then press coated with polymers to release the drug in early morning hours after predetermined lag period. Carrageeenan and xanthum gum were used as release rate retarding polymers. FTIR studies were conducted to check interaction between drug and inactive ingredients. Evaluation tests like hardness, thickness, friability, weight variation, disintegration time and dissolution tests were carried out for prepared tablets. Dissolution tests were conducted in 0.1 N Hcl acidic buffer for 120 minutes and in phosphate buffer pH 6.8 for remaining 6 hours in USP dissolution apparatus. Core tablets initially released 95.85% drug in 60 minutes and press coated tablets released 98.82 % drug after 8 hours. Accelerated stability studies were carried out for 90 days. Formulation KP-14 of ketoprofen containing Ac di sol and Explotab as super disintegrant and Carrageeenan and xanthum gum as rate controlling polymers has shown better micromeritic properties, less weight variation, high drug content, better hardness, less friability, quick disintegration time and dissolution profile among all the formulations. Hence formulation KP-14 containing ketoprofen is chosen as best optimized formulation after carrying out all evaluation tests. Keywords: Pulsatile drug delivery system, Ac-di-sol, SSG, pharmacokinetics, LOD, Press coating.
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4. | ANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY NEW UPLC METHOD FOR THE DETERMINATION OF SACUBITRIL IN TABLET DOSAGE FORM |
| A. Srikanth* and M. Purushothaman |
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A simple accurate, precise rapid isocratic RP-UPLC method development for the simultaneous estimation of Sacubitril in tablet dosage form .The chromatographic system was carried on Sunfire BEH Phenyl(100x2.0 mm) 1.5µm using mobile phase consisting of a 75 volumes of Buffer, 25 volumes of Acetonitrile with detection of 230 nm.. The retention time of Sacubitril was found to be 1.303 min calibration curve was linear over the concentration range of Sacubitril the correlation coefficient for both peak was found to be 0.999 respectively. All the analytical validation parameters were determined and found in the limit as per ICH guidelines. Keywords: Sacubitril, UPLC.
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5. | SIMULTANEOUS ESTIMATION OF ERGOTAMINE AND CAFFEINE IN THEIR TABLET FORMULATION |
| Srikanth A*, Shiva Kumar Tejavath, R. Shankar Sheshu, S. Selva Kumar |
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Caffeine is most commonly used to improve mental alertness, but it has many other uses. Caffeine is used by mouth or rectally in combination with painkillers (such as aspirin and acetaminophen) and a chemical called ergotamine for treating migraine headaches. Ergotamine is in a class of medications called ergot alkaloids. It works together with caffeine by preventing blood vessels in the head from expanding and causing headaches. This combination medication is used to treat or prevent certain types of headaches (vascular headaches including migraine and cluster headaches). The developed UV-Visible Spectrophotometric method for the simultaneous estimation of ergotamine and caffeine in the tablet dosage form in the solvent system methanol and distilled water 1:1 ratio give proper estimation of percentage label claim of marketed product
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