Development of Stability Indicating RP-HPLC Method for Determination of Levosulpiride Hydrochloride In Bulk And Pharmaceutical Dosage Form

A rapid, specific and sensitive stability indicating reverse phase high performance liquid chromatographic method has been developed and validated for analysis of levosulpiride hydrochloride in both bulk and pharmaceutical dosage form. An isocratic stability indicating reversed-phase liquid chromatographic determination was developed for the quantitative determination of levosulpiride in the pharmaceutical dosage form. A sunfire C-18, 4.5mm column with mobile phase containing methanol-water (10:90, v/v) was used. The flow rate was 1.0 mL min -1 and effluents were monitored at 232 nm. The retention time of Levosulpiride was 5.5 min. Levosulpiride stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, wet hydrolysis, dry heat degradation and sun light degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time values. Stressed samples were assayed using developed LC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of Levosulpiride in tablet dosage forms. The proposed study describes stability indicating LC method for the estimation of Levosulpiride in bulk and their pharmaceutical dosage form. The method is suitable for the routine analysis of Levosulpiride in tablets

Quantification of cinnarizine and dimenhydrinate in tablet dosage form by simultaneous equation spectrophotometric method

Simple, accurate, precise, reproducible, requiring no prior separation and economical procedures for simultaneous estimation of Cinnarizine(CNZ) and Dimenhydrinate(DMH) in tablet dosage form have been developed. Method employs formation and solving of simultaneous equation using 250 nm and 277 nm as two analytical wavelengths for both drugs in methanol. CNZ and DMH at their respective ? max 250 nm and 277 nm shows linearity in a concentration range of 2-12 ?g /ml and 10-35 ?g /ml. Recovery studies for CNZ 98.9-100.75% and 96.16-100.69% for DMH in case of simultaneous equation method confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since it is rapid, simple, accurate and also sensitive and specific

Development and Validation of a Stability-Indicating RP-HPLC Method for Duloxetine Hydrochloride in its Bulk and Tablet Dosage Form

The objective of the present work was to develop a stability-indicating RP-HPLC method for duloxetine hydrochloride (DUL) in the presence of its degradation products generated from forced decomposition studies. The drug substance was found to be susceptible to stress conditions of acid hydrolysis. The drug was found to be stable to dry heat, photodegradation, oxidation and basic condition attempted. Successful separation of the drug from the degradation products formed under acidic stress conditions was achieved on a Hypersil C-18 column (250 mm × 4.6 mm id, 5μm particle size) using acetonitrile: 0.01 M potassium dihydrogen phosphate buffer (pH 5.4 adjusted with orthophosphoric acid) (50:50, v/v) as the mobile phase at a flow rate of 1.0 ml/min. Quantification was achieved with photodiode array detection at 229 nm over the concentration range 1–25 μg/ml with range of recovery 99.8–101.3 % for DUL by the RP-HPLC method. Statistical analysis proved the method to be repeatable, specific, and accurate for estimation of DUL. It can be used as a stability-indicating method due to its effective separation of the drug from its degradation products

Thin-layer chromatography method for the simultaneous quantification and stability testing of alprazolam and mebeverine in their combined pharmaceutical dosage form

A sensitive, selective and precise high-performance thin-layer chromatographic method was developed and validated for the simultaneous determination of alprazolam and mebeverine, both as bulk drugs and in formulations. The method employed HPTLC aluminium plates that had been pre-coated with silica gel 60F-254 as the stationary phase, while the solvent system was acetone:methanol:acetic acid (6:4:0.1, v/v/v). The Rf values of alprazolam and mebeverine were observed to be 0.80 ± 0.08 and 0.60 ± 0.05, respectively. The densitometric analysis was carried out in absorbance mode at 225 nm. The linear regression analysis for the calibration plots showed a good linear relationship for alprazolam and mebeverine over concentration ranges of 600 to 3600 ng/spot and 1000 to 6000 ng/spot, respectively. The limit of detection and the limit of quantification for alprazolam (mebeverine) were determined to be 63.97 (11.35) ng/spot and 193.85 (34.40) ng/spot, respectively. Alprazolam and mebeverine stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo-degradation. Both drugs were found to be susceptible to acid and alkali hydrolysis, chemical oxidation and photo-degradation, whereas both were found to be stable towards dry heat. The degraded product peaks were well resolved from the pure drug peak and displayed a significant difference in their Rf values. Stressed samples were assayed using the developed HPTLC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of alprazolam and mebeverine in marketed formulations. Statistical analysis showed that the method is repeatable, selective, and precise

Stability-indicating liquid chromatographic method for quantification of new anti-epileptic drug lacosamide in bulk and pharmaceutical formulation

An isocratic stability indicating reversed-phase liquid chromatographic determination was developed for the quantitative determination of lacosamide in the pharmaceutical dosage form. A Hypersil C-18, 4.5μm column with mobile phase containing acetonitrile-water (20:80, v/v) was used. The flow rate was 1.0 mL min-1 and effluents were monitored at 258 nm. The retention time of lacosamide was 8.9 min. The method was found to be linear in the concentration range of 5-100 μg/ml and the recovery was found to be in the range of 99.15 - 100.09 %. The limit of detection and limit of quantification were found to be 2 μg/ml and 5 μg/ml, respectively. Lacosamide stock solutions were subjected to acid and alkali hydrolysis, chemical oxidation and dry heat degradation. The drug was found to be stable to the dry heat and acidic condition attempted. The proposed method was validated and successfully applied to the estimation of lacosamide in tablet dosage forms

Analytical Rp-hplc Method for Development and Validation of Citicoline Sodium and Methylcobalamin in Combined Tablet Formulation

Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method have been developed and validated for theestimation of Citicoline Sodium and Methylcobalaminin Bulk drug and Pharmaceutical dosage form. The developedmethod is rapid, accurate, precise, simple and economical than the previous methods. The separation was carried outusingPhenomenex Luna , C18, column having 250mm X 4.6mm, 5?m particle size, in isocratic mode, with mobile phase containing Acetonitrile: 0.02M KH2PO4 [60: 40, v/v]. The flow rate is 1 ml / min and effluents are monitored at 554 nm. Chromatogram showed peak at a retention time of 3.8 min for Citicoline sodium and 2.3 min for Methylcobalamin . The method is validated for system suitability, linearity, precision, accuracy specificity, ruggedness, robustness, LOD and LOQ. Recovery of Citicoline Sodium and Methylcobalamin is found to be in the range of 99.76 - 101.79 % and 110.92% and 111.79%, respectively. The LOD and LOQ for estimation of Citicoline Sodium and Methylcobalamin are found to be 0.003 ?g / ml, 0.0.01 ?g / ml, and 0.01?g / ml, 0.05 ?g / ml respectively. Proposed method can be successfully applied for the quantitative determination of Citicoline Sodiumand Methylcobalamin in Bulk drug and Pharmaceutical dosage form