A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Itopride HCl in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Welchrom C18Column (4.6 X 250mm, 5µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50v/v). The flow rate was set to 1.0 mL.min-1 with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Itopride HCl was found to be 2.650 min. Linearity was established for Itopride HCl in the range of 2-10 µg.mL-1 with correlation coefficient 0.9999. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Itopride HCl in pharmaceutical tablet dosage form.
Objective: The objective of the current study was to develop and validate a novel RP-HPLC method for determination of bamifylline hydrochloride in pharmaceutical dosage form.
Methods:Chromatographic separation was conducted on Agilent technologies-1260 series with the G1311C quaternary pump, eclipse XDB C18 column (4.6 mm i.d. X 250 mm, 5 µm particle sizes) and equipped with photodiode array detector G1315D. Mobile phase consisted of methanol and acetonitrile were mixed in the ratio of 90:10 v/v, was used at a flow rate of 1 ml/min and detection wavelength was set at 263 nm.
Results:The retention time for bamifylline hydrochloride was found to be 2.913 min. The calibration was linear (r 2 = 0.9996) in the concentration range of 2-10 µg/ml. The limit of detection and the limit of quantitation were found to be 0.4825 μg/ml and 1.4621 µg/ml respectively. Recovery of bamifylline hydrochloride in tablet formulation was observed in the range of 99.6-99.8 %. Percentage assay of bamifylline hydrochloride (Bamifix) was found to be 99.4 % w/w.
Conclusion:Thus the novel proposed method for bamifylline hydrochloride was found to be feasible for the estimation of bamifylline hydrochloride in bulk as well as a pharmaceutical dosage form.
Objective: Objective of the present investigation is to develop a speedy isocratic reverse phase high-performance liquid chromatography (RP-HPLC) method for the separation and quantitative determination of 5 angiotensin II -receptor antagonists, namely, telmisartan, losartan, valsartan, olmesartan, irbesartan, and atenolol along with thiazide diuretics mostly hydrochlorothiazide (HCTZ).Methods: RP-HPLC method was evolved using Welchrom C 18 column (4.6 × 250 mm, 5 µm) as a stationary phase with the mobile phase comprising a variety of phosphate buffer with pH-3.3 and acetonitrile in the proportion of 50:50 v/v. The mobile phase was pumped at a current rate of 1 mL/minute. The detection wavelength was carried out at 230 nm.
Results:The total run time was 6 minutes and the elution window of only 3 minutes. The peaks were eluted with decorous resolution. The calibration curves were linear (r 2 =0.9998) in all cases. The percentage relative standard deviation (RSD%) was <2% and average recovery was above 99.95%. The method was validated specificity, precision, and accuracy. High recovery values and low RSD% prove that this method is very accurate and reproducible. The developed method was applied to the estimation of the above-said drugs in binary combinations from different manufacturers which were a good agreement with label claim.
Conclusion:The important advantage of developed method was that the five individual drugs can be determined on a single chromatographic system without alteration in detection wavelength and mobile phase composition. This novel method was statistically validated as per ICH guidelines. The optimized method proved to be linear, accurate, and robust. Hence, the above said proposed method was found to be a rapid tool for the routine determination of the above-said drugs in alone or combination with HCTZ in quality control analysis without interference of excipients.
A selective, sensitive and accurate HPLC method with UV detection was developed and validated for the separation of five anti-hypertensive agents and applied for the determination of hydrochlorothiazide in bulk and pharmaceutical dosage forms. One of the key goals of HPLC technique is to achieve a consistent and reproducible separation. RP-HPLC method was developed by using Welchrom C 18 Column (4.6 mm i.d. X 250 mm, 5 µm particle size), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase constituted of 10 mM Phosphate buffer (pH3.0, adjusted with triethylamine): acetonitrile (50:50, v/v).The flow rate was set to 1.0 mL/min with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Visible detector. The retention times of atenolol hydrochloride, metoprolol succinate, hydrochlorothiazide, amlodipine besylate and nebivolol hydrochloride were found to be 2.303 min, 2.827 min, 3.543 min, 4.253 min and 4.957 min respectively. This method successfully separated all five antihypertensive drugs in less than 6 min. Hydrochlorothiazide was found to give linear response in the concentration range of 2-10µg/mL. Recovery studies were performed to ascertain the accuracy by standard addition method and average recovery was found to be 99.70 to 100.17 %.The limit of detection and limit of quantification were found to be 0.126616 µg/mL and 0.383686 µg/mL respectively. The developed method can be used for routine quality control analysis of hydrochlorothiazide in pharmaceutical tablet dosage form. It can also be extended for the determination of other four anti-hypertensive agents. This method provides simple and fast method with excellent peak symmetry and high resolution.
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