Paresh U. Patel

This research manuscript describes simple, sensitive, accurate, precise and repeatable reverse phase high performance liquid chromatography method for the estimation of Ketoconazole in tablet dosage form. The sample was analyzed by reverse phase ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) as stationary phase; methanol: acidic water  [91:9, v/v] pH 3.0 as a mobile phase at a flow rate of 0.85 ml/min. Quantification was achieved with Photo Diode Array detector at 243 nm. The retention time for Ketoconazole was found to be 2.764 min. The linearity was obtained in the concentration range of 5-40 µg/ml for Ketoconazole. The method was successfully applied to tablet because no chromatographic interferences from formulation excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.

This research manuscript describes simple, sensitive, accurate, precise and repeatable reverse phase high performance liquid chromatography method for the estimation of Chlorhexidine gluconate in mouthwash. The sample was analyzed by reverse phase ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) as stationary phase; acetonitrile : methanol : triethyl Amine (0.1 %) PH 3.0 (22: 49: 29, v/v/v) as a mobile phase at a flow rate of 0.8 ml/min. Quantification was achieved with Photo Diode Array detector at 258 nm. The retention time for chlorhexidine gluconate was found to be 2.477 min. The linearity was obtained in the concentration range of 10 -80 µg/ml for chlorhexidine gluconate. The method was successfully applied to mouthwash because no chromatographic interferences from formulation excipients were found. The method retained its accuracy and precision when the standard addition technique was applied.

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of diclofenac sodium and eperisone hydrochloride in bulk and synthetic mixture. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Eperisone hydrochloride and diclofenac sodium show an isoabsorptive point at 270 nm in methanol. The second wavelength used is 255 nm, which is the λ-max of eperisone hydrochloride in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both eperisone hydrochloride and diclofenac sodium. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of eperisone hydrochloride. The method was successfully applied to pharmaceutical dosage form because no interference from the synthetic mixture excipients was found. The suitability of this method for the quantitative determination of eperisone hydrochloride and diclofenac sodium was proved by validation. The proposed method was found to be simple and sensitive for the routine quality control application of eperisone hydrochloride and diclofenac sodium in synthetic mixture or pharmaceutical dosage form. The results of analysis have been validated statistically and by recovery studies. 

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of ibuprofen and chlorzoxazone in bulk and synthetic mixture. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Ibuprofen and Chlorzoxazone show an isoabsorptive point at 227 nm in methanol. The second wavelength used is 221 nm, which is the λ-max of Ibuprofen in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both Ibuprofen and Chlorzoxazone. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of Ibuprofen. The method was successfully applied for the determination of these two drugs in synthetic mixture. No interference was observed from excipients present in the synthetic mixture. The suitability of this method for the quantitative determination of Ibuprofen and Chlorzoxazone was proved by validation. The proposed method was found to be simple and sensitive for the routine analysis of these two drugs in synthetic mixture. The results of analysis have been validated statistically and by recovery studies. 

A simple, specific, selective and accurate stability-indicating reversed phase high performance liquid chromatographic method was developed for simultaneous determination of Diclofenac potassium (DIC), Paracetamol (PCM) and Methocarbamol (MET). An isocratic RP-HPLC was achieved on younglin HPLC system using Varian C18 (250 Χ 4.6 mm i.d, 5 μm particle size) column with the mobile phase containing mixture of Methanol:water (80:20,v/v). The flow rate was 0.8 ml/min and the eluent was monitored at 225nm. The retention times of DIC, PCM and MET were found to be 3.51, 6.42 and 9.90 min respectively. The linearity was established for DIC, PCM and MET in the range of 10-60 µg/ml, 65-390µg/ml, 100-600µg/ml respectively. The percentage recoveries of DIC, PCM and MET were found to be in the range of 99.73%±0.109, 99.59%±0.085 and 99.50%±0.16 respectively. The LOD for DIC, PCM and MET were found to be 0.15, 2.40 and 1.82μg/ml respectively, while LOQ were 0.48, 7.29 and 5.53μg/ml respectively. All three drugs were subjected to acid, alkali, oxidation, and dry heat degradation. The degradation studies indicated DIC, PCM and MET showed degradation in acid, alkaline, H2O2, and in dry heat condition. The degradation products of DIC, PCM and MET were resolved well from the pure drug with significant differences in their retention time values. This method was also successfully employed for simultaneous quantitative analysis of DIC, PCM and MET in bulk drugs and formulations. The developed method is stability indicating and separate degradants and can be used to determine the stability of samples.

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical derivative spectroscopic method for the simultaneous determination of tolperisone hydrochloride (TOL) and diclofenac sodium (DIC) in bulk and synthetic mixture. Derivative spectroscopy offers a useful approach for the analysis of drugs in mixtures. In this study a first-derivative spectroscopic method was used for simultaneous determination of tolperisone hydrochloride and diclofenac sodium using the zero-crossing technique. The measurements were carried out at wavelengths of 250.60 and 311.20nm for tolperisone hydrochloride and diclofenac sodium respectively. The method was found to be linear (r2>0.9970) in the range of 5- 40 μg/ml for tolperisone hydrochloride at 250.60 nm. The linear correlation was obtained (r2>0.9990) in the range of 5-50 μg/ml for diclofenac sodium at 311.20 nm. The limit of determination was 0.65 and 0.55 μg/ml for tolperisone hydrochloride and diclofenac sodium respectively. The limit of quantification was 2.01 and 1.67 μg/ml. The method was successfully applied for simultaneous determination of tolperisone hydrochloride and diclofenac sodium in binary mixture.

Floating dosage form for gastric retention has potential to use as controlled-release drug delivery systems which providing opportunity for both local and systemic drug action. The present work was aimed to formulate controlled release floating tablet (CRFT) of Perindopril Erbumine using gas generated low density approach. To develop CRFT, the Perindopril Erbumine was selected as a drug because it complies with the suitability criteria for the floating drug delivery system and the controlled release medication was required due to its potent action and poor bioavailability. The present investigation was suggested that the bioavailability of Perindopril Erbumine was improved due to increased gastric retention time and controlling the drug release rate using the natural polymer SFG, HPMCK15M and Acrypol 934. The CRFT of Perindopril Erbumine was developed by using wet granulation method and PVP K 30 was used as a granulating agent. The study was given the assurance that SFG had an excellent controlled drug releasing property then HPMCK15M by forming matrix in the formulation. The Acrypol 934 was added to control the drug release rate in to formulation and found good compressibility and controllable drug releasing properties in to the final formulation. All the formulation was evaluated for Weight variation, Thickness, Hardness, Diameter, Friability, Assay, FLT, TFT, Swelling Index and Dissolution study. Key Word: CRFT, SFG, Acrypol 934, FLT, TFT, SWI, Perindopril Erbumine, DSC