The day by day new combinations drugs are being launched in market. Then the multiple therapeutic agents which acts at diverse sites are used in the management of various diseases and disorders are done. Thus it is necessary to develop methods for analysis with the help of number of analytical methods which are available for the estimation of the drugs in combination. The analyst were estimate the rapid, selective, specific, simple, RP-HPLC method is developed and validated for simultaneous estimation of Sofosbuvir and Ledipasvir in pharmaceutical tablet dosage form. RP-HPLC method was performed on the Inertsil-ODS HPLC System equipped with SP930 D HPLC pump and dual wavelength UV-VIS detector and C18 column (250mm × 4.6mm, 5μm), using the mobile phase (Methanol: Water 60:40 v/v) pH 3.0 with 0.05% acidic acid at a flow rate of 1.0ml/min, injection volume 20μl and UV detection at 254nm. This method is validated according to BP, USP and ICH requirements for new methods, which include accuracy, precision, robustness, ruggedness, lod, loq, linearity and range. Linear relationships were obtained in the ranges of 20-80μg/ml and 20-80μg/ml with correlation coefficients of 0.9991 and 0.9994 at Rt value of 3.94min and 2.86min for Sofosbuvir and Ledipasvir respectively. According to ICH guidelines the developed method was validated. The proposed method can be used for estimation of these drugs in combined pharmaceutical dosage forms.
V. Dhivya*, S. S. Rajendran, N. Santhi, W. D. Sam Solomon, J. Anudeepa.
The current research work is validated RP-HPLC method developed and validated for simultaneous determination of Metformin and Sitagliptin in pure and combined tablet dosage forms. An accurate, precise and reproducible high performance liquid chromatographic method was developed for quantitative estimation of Metformin and Sitagliptin simultaneously in tablet dosage forms. Shimadz SPD 10A (S.K.) gradient System UV Detector and C18 (Primesil) column with 250mm x4.6mm i.d. and 5μm particle size. Distilled water: Methanol 0.05% Ortho phosphoric acid (50:50) composition of solvent system used as the mobile phase for the method. The detection wavelength was 241nm and flow rate was 1.0ml/min. In the developed method, the retention time of Metformin and Sitagliptin were found to be 2.1min and 7.6min. The proposed research method was validated according to the ICH guidelines. The range, calibration curve, accuracy and precision, robustness was within the limits as specified by the ICH guidelines. So the proposed methods can be used for the routine quality control analysis of Metformin and Sitagliptin simultaneously in tablet dosage forms.
Gandla. Kumara Swamy*, Repudi. Lalitha, Bathula. Annu, M. Lakshi Surekha.
A simple, sensitive, accurate and economic reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous determenation of Fluoxetine hydrochloride and Olanzapine in pharmaceutical dosage forms. The mobile phase consisted of degassed Methanol: Acetonitrile in the ratio of 90:10 v/v delivered at a flow rate of 1.0ml/min and wavelength of detection at 233nm. The retention times of Fluoxetine and Olanzapine were 2.95min and 3.53min respectively. According to ICH guidelines the method was developed and validated. The proposed method can be used for estimation of these drugs in combined pharmaceutical dosage forms.
Meenu Markose*, S. S. Rajendran, N. Santhi, J. Anudeepa, W. D. Sam Solomon.
This manuscript aims to illustrate chemoselective hydrolysis of Di-pentyldiacetyl capecitabine by using Immozyme CAL B -T3-150 therefore preparation of novel Di-pentyloxycarbonyl capecitabine analogue and it’s impact on active pharmaceutical ingredient capecitabine.
We describe a simple and robust analytical method based on capillary electrophoresis for qualitative and quantitative analysis of two antibiotics, doxycycline and ampicillin, that were purchased in Lao PDR and Cambodia. Alow-cost capillary electrophoresis apparatus, originally developed for teaching purposes and/or operating in remote areas and harsh conditions, was utilized in this study. Analyses of the two antibiotics were performed in an uncoated fused-silica capillary filled with a sodium phosphate buffer (10mM; pH = 2.3). The solute detection was accomplished by UV absorption at 200nm. Histidine was employed as an internal standard and the correlation coefficients of doxycycline and ampicillin were determined as 0.9997 and 0.9992, respectively. In total, 18 samples of doxycycline and 19 samples of ampicillin were analyzed. Among the 18 doxycycline samples, only two had a percentage of active pharmaceutical ingredient content that did not fall inside the 85% - 115% range, while we found 13 out of 19 ampicillin samples that were out of this range. We also analyzed doxycycline and ampicillin obtained from a pharmacy in France, as two control samples, and in both cases we found the percentage of active ingredient content close to 100% (98, 9% for doxycycline and 98, 3% for ampicillin). This study was carried out as part of a training process, initiated by Pierre-Fabre foundation, of two PhD students from Lao PDR and Cambodia that will integrate this method into a teaching process at pharmacy schools in their respective countries.
Pierre Perioand Jan Sudor*, Chiobouaphong Phakeovilay, Monivan Chhour.