Kalpesh V. Sonar

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Fosfomycin in Fosfomycin for Injection. The drug is freely soluble in analytical grade water 1. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics 2. It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity 4, 5, 6. The UV spectroscopic method was developed for estimation of Fosfomycin in injection dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade water, slightly soluble in 95% Methanol and Ethanol. Almost insoluble in anhydrous acetone, ether and chlorinated solvent. So, the analytical grade water is used as a diluent in method. The melting point of Fosfomycin was found to be 94 - 95?C (uncorrected). It showed absorption maxima 254 nm in analytical grade water. On the basis of absorption spectrum the working concentration was set on 50µg/ml (PPM). The linearity was observed between 30-70 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.41%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Fosfomycin in Fosfomycin for Injection dosage form. The method could be considered for the determination of Fosfomycin in quality control laboratories.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Valsartan in tablet dosage form. The drug is freely soluble in analytical grade Ethanol, Methanol and Acetonitrile. The drug was identified in terms of solubility studies and on the basis of melting point done on Melting Point Apparatus of Equiptronics. It showed absorption maxima were determined in diluent Methanol: Water (50:50) ratio. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Valsartan in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade Ethanol, Methanol, Acetonitrile and sparingly soluble in water. So, the analytical grade Methanol: water (50:50) is used as a diluent in method. The melting point of Valsartan was found to be 115-116?C (uncorrected). It showed absorption maxima 250 nm in Methanol: Water (50:50) ratio. On the basis of absorption spectrum the working concentration was set on 20µg/ml (PPM). The linearity was observed between 10-30 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.35%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Valsartan in tablet dosage form. The method could be considered for the determination of Valsartan in quality control laboratories. Keywords: Valsartan, Development, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.

Bilayer tablet is the novel technology for the development of controlled release formulation. Developing a combination of two or more active pharmaceutical ingredients in a single dosage form is known as a bilayer tablet. Bilayer tablet is more suitable for gradual release of two active ingredients in combination. The preparations of bilayer tablet were needs due to separate incompatible active pharmaceutical ingredient (APIs) for each other. Bilayer tablets material involves both the compressibility and consolidation. The primary objective of sustained release drug delivery is to ensure safety and to improve efficacy of drugs as well as patient compliance. Bi-layer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one layer is immediate release as initial dose and second layer is maintenance dose. Bilayer tablet is improved beneficial technology to overcome the shortcoming of the single layered tablet. In the case of bi-layered tablets drug release can be rendered almost unidirectional if the drug can be incorporated in the upper non-adhesive layer its delivery occurs into the whole oral cavity. Keywords: Active Pharmaceutical Ingredient, Bi-layer tablet

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Ivabridine HCl in tablet dosage form. The drug is freely soluble in analytical grade water. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade water. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Ivabridine HCl in tablet dosage form and also validated as per ICH guidelines. The drug is soluble in analytical grade water, slightly soluble in methanol and freely soluble in ethanol. So, the analytical grade water is used as a diluent in method. The melting point of Ivabridine HCl was found to be 194-195?C (uncorrected). It showed absorption maxima 260 nm in analytical grade water. On the basis of absorption spectrum the working concentration was set on 6µg/ml (PPM). The linearity was observed between 2-10 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 98.33 and 101.25% for three levels respectively. The % RSD for precision was found to be 0.54%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Ivabridine HCl in tablet dosage form. The method could be considered for the determination of Ivabridine HCl in quality control laboratories. Keywords: Ivabridine HCl, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Guaifenesin in tablet dosage form. The drug is freely soluble in analytical grade Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Guaifenesin in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade Methanol, moderately soluble in Benzene and soluble in Chloroform, Glycerol. So, the analytical grade Methanol is used as a diluent in method. The melting point of Guaifenesin was found to be 78-79ËšC (uncorrected). It showed absorption maxima 269 nm in analytical grade Methanol. On the basis of absorption spectrum the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.97%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Guaifenesin in tablet dosage form. The method could be considered for the determination of Guaifenesin in quality control laboratories.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Lansoprazole in Capsule dosage form. The drug is soluble in analytical grade Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Lansoprazole in Capsule dosage form and also validated as per ICH guidelines. The drug is freely soluble in Dimethylformamide, soluble in analytical grade Methanol, sparingly soluble in Ethanol, slightly soluble in Ethyl Acetate, Dichloromethane and Acetonitrile. So, the analytical grade Methanol is used as a diluent in method. The melting point of Lansoprazole was found to be 179-180ËšC (uncorrected). It showed absorption maxima 285 nm in analytical grade Methanol. On the basis of absorption spectrum the working concentration was set on 10µg/ml (PPM). The linearity was observed between 6-14 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 99.00 and 100.80 % for three levels respectively. The % RSD for precision was found to be 0.9039 %.A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Lansoprazole in Capsule dosage form. The method could be considered for the determination of Lansoprazole in quality control laboratories.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Acebrophylline in tablet dosage form. The drug is freely soluble in analytical grade Ethanol. The drug was identified in terms of solubility studies and on the basis of melting point done on melting point apparatus of Equiptronics. It showed absorption maxima were determined in analytical grade Ethanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of acebrophylline in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade Ethanol, slightly soluble in methanol and water. So, the analytical grade Ethanol is used as a diluent in method. The melting point of acebrophylline was found to be 213-214ËšC (uncorrected). It showed absorption maxima 251 nm in analytical grade Ethanol. On the basis of absorption spectrum the working concentration was set on 10µg/ml (PPM). The linearity was observed between 2-18 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.95%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Acebrophylline in tablet dosage form. The method could be considered for the determination of Acebrophylline in quality control laboratories.

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Ranolazine in tablet dosage form. The drug is freely soluble in analytical grade methanol. The drug was identified in terms of solubility studies and on the basis of melting point which was done on melting point apparatus of Equiptronics. Ranolazine showed absorption maxima were determined in analytical grade methanol. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Ranolazine in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade methanol, slightly soluble acetonitrile and very slightly soluble in analytical grade water. So, the analytical grade methanol is used as a diluent in method. The melting point of Ranolazine was found to be 120-122ËšC (uncorrected). It showed absorption maxima 235 nm in analytical grade methanol. On the basis of absorption spectrum the working concentration was set on 8 µg/ml (PPM). The linearity was observed between 2-12 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101 and 98.33% for three levels respectively. The % RSD for precision was found to be 0.6353% which was within acceptance criteria as per ICH guidelines. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Ranolazine in tablet dosage form. The method could be considered for the determination of Ranolazine in tablet dosage form in quality control laboratories.

Albendazole (ALB), chemically known as methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate is widely used as an anthelmintic having a wide spectrum of activity. Numerous numbers of analytical methods are there for the simultaneous estimation of bulk and in formulation, such as spectrophotometry and liquid chromatography. As the UV spectrophotometric method is rapid, simple, accurate and economical, the method has been developed for the assay of the albendazole in pharmaceutical formulation. The wavelengths selected for the method were at 291 nm. The results of analysis have been validated by recovery studies as per ICH guidelines. The developed method was rapid, simple, accurate and economical and it can be used for routine quality control analysis. It showed absorption maxima at 291 nm in analytical grade DMF. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity.