Tablet.

A new, simple and sensitive UV-spectrophotometric method was developed for the determination of Benfotiamine in bulk and tablet dosage form. This method, involves the measurement of absorbances of Benfotiamine at the wavelength of 244nm. 0.1M HCl was used as solvent. Linearity was observed in the concentration range of 3-18µg/ml with correlation coefficient 0.999. The accuracy of the method was confirmed by recovery studies of tablet dosage forms and was found to be 99.32%-100.42% for Benfotiamine. The method showed good reproducibility and recovery with %RSD lessthan 2.0. The LOD and LOQ of Benfotiamine was found to be 0.051μg/ml and 0.155μg/ml. Results of the analysis were validated for accuracy, precision, LOD, LOQ and were found to be satisfactory. Thus the developed method was found to be simple, sensitive, rapid, precise, accurate and cost effective quality control tool for the routine analysis of Benfotiamine in bulk and tablet dosage form.

Cetrizine hydrochloride and Phenylephrine hydrochloride are used in combination in the treatment of allergy. The aim of this project work is to develop selective, accurate, specific and economic RP–HPLC method for simultaneous estimation of Cetrizine hydrochloride and Phenylephrine hydrochloride in Bulk and Tablet dosage form. The reverse phase C18 (250 mm × 4.6 mm i.d) column with 5 µm particle size was used. Acetonitrile: Water was taken as mobile phase was with a flow rate of 1 mL/min and detection was carried out at 222 nm. The retention time of Cetrizine hydrochloride and Phenylephrine hydrochloride was 1.956 min and 4.561 min respectively. The calibration curves were linear (>0.998) in the range of 5-25 μg/ml for Cetrizine hydrochloride and Phenylephrine hydrochloride. The Limit of Detection for Cetrizine hydrochloride and Phenylephrine hydrochloride was found to be 0.26 μg/mL and 0.51μg/mL. The Limit of Quantification was found to be 0.81μg/mL and 1.54 μg/mL respectively for Cetrizine hydrochloride and Phenylephrine hydrochloride. The developed method was simple, selective and precise and can be used for routine analysis of Cetrizine hydrochloride and Phenylephrine hydrochloride in tablet dosage form.

  The objective of designing a dosage form is to achieve predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. In order to ensure quality of product various features are required, like chemical and physical stability, preservation against microbial contamination, uniformity of dose of drug, acceptability to users including prescriber and patient, as well as suitable packing, labeling, and validation. The present research work focused on prospective process validation for the gliclazide 40mg tablet. Tablet was manufactured by wet granulation method. Formulation of tablet using Maize Starch, Avicel Ph 102, PVP-K30, sodium starch glycolate, Purified Talc, Aerosil 200 and  Magnesium stearate. Uniformity of dry mixing is excellent in 10min because % RSD found to be 0.4267-0.9021%. Granulating agent was prepared of desired consistency. Drying time 30 min is sufficient to achieve LOD 2-3%. Evaluation parameter of sizing shows effective LOD, % fine, BD & CI. Lubrication stage uniformity was achieved with 10min because % RSD found 0.8320-1.032% and flow properties was satisfactory. Compression machines optimum speed (20RPM) was satisfactory for effective compression. Based on results at each of the stages for the specified parameters it is concluded that gliclazide tablets can be effectively prepared with the desired specification & reproducible quality standards.