RP-HPLC

This research introduces a straightforward, rapid, sensitive, and selective analytical method for measuring daprodustat in both bulk powder and tablet forms. The techniques used include UV-Visible spectrophotometry and reversed-phase high-performance liquid chromatography (RP-HPLC). For the UV-Visible method, a Systonic AU-2702 double-beam spectrophotometer was used to measure Daprodustat 's absorbance at 265 nm. The RP-HPLC procedure employed a Shimadzu SPD-10A C18 column (250×4.6 mm, 5 µm). The mobile phase consisted of a mixture of acetonitrile and distilled water (70:30, v/v), with 0.1% formic acid added. Key operational parameters included a flow rate of 1.2 mL/min, an injection volume of 10 μL, and a column temperature of 30 °C. The method's linearity ranged from 10 to 100 μg/mL. The entire procedure was validated following ICH Q2 (R1) guidelines, confirming its specificity, linearity, sensitivity, precision, accuracy, robustness, and system suitability. The technique yields highly sensitive results, with Limits of Detection (LODs) and Limit of Quantification (LOQs) of 0.6174 μg/mL and 1.87μg/mL for daprodustat. Recovery rates ranged from 98% to 102%, and both intra-day and inter-day precision (measured by % RSD) were below 2%. The method demonstrated excellent specificity, avoiding interference from excipients or formulation matrices. Overall, this study provides a complete analytical framework applicable for routine pharmaceutical analysis, ensuring quality control, safety assessment, and regulatory compliance for daprodustat.   

Current study has developed two precise and direct RP-HPLC approaches for quantitative investigation of glimepiride (GLM) in both mass and pharmaceutical formulations. Glimepiride was analyzed using the RP-HPLC method with C-18 stationary phase and mobile phase of methanol and phosphate buffer (PBS) at pH 4.0 in equivalent volume ratio. The location was established at 239 nm wavelength, and the adaptable stage was extracted at a rate of 0.5 mL/mi. The retention time was observed at 2.470 minutes. Present approach was authenticated in terms of linearity, accurateness, precision, system applicability, limit of detection (LOD), limit of quantification (LOQ), robustness, and ruggedness. It has been demonstrated that the suggested approach is appropriate for monotonous examination of glimepiride in dose and bulk forms, yielding precise results. This method was employed to determine a compound's concentration in commercial pharmaceutical dosage forms. In comparison to alternative chromatographic techniques, this method is more direct, precise, and reproducible, rendering it a superior choice for routine quality control.

A rapid stability-indicating RP-HPLC was developed and validated for the estimation of Mirabegron and Solifenacin combination in bulk and tablet dosage form using Thermo C18 column (250 x 4.6 mm, 5m) as a stationary phase and a mixture solution of 0.1 percent Diazanium sulphate buffer: Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1 ml/min. A photodiode array detector was used for detection at 246 nm. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were all determined. The peak area response-concentration curve was rectilinear over the concentration ranges of 25-75 g/ml (Mirabegron) and 2.5-7.5 g/ml (Solifenacin), with quantitation limits of 0.793 g/ml (Mirabegron) and 0.307 g/ml (Solifenacin). The proposed method was validated for the simultaneous determination of mifepristone and misoprostol in combined tablet dosage form. In comparison to previously reported RP-HPLC methods, the performance of the proposed method was found to be rapid and cost-effective. The developed and validated stability-indicating RP-HPLC method was suitable for quality control and drug analysis.

The present study describes the development and subsequent validation of Reverse phase HPLC (RP-HPLC) method for the analysis of Imeglimin hydrochloride. A novel economic, simple, rapid, accurate, reproducible, and precise Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for Imeglimin hydrochloride. The method was performed on a YOUNG LIN-HPLC system-ACME9000. The method developed for Imeglimin hydrochloride was quantitatively measured using an isocratic RP-HPLC methodology. The chromatographic separation of Imeglimin hydrochloride was achieved on RP-HPLC equipped with Hypersil BDS C18 (250mm x 4.6mm, 5 um) column using isocratic elution with a mobile phase consisting of MeOH: Buffer in a ratio of (70:30% v/v) at a flow rate of 1.0ml/min with an injection volume of 20µl, where detection was carried out by UV- 730D detector at 239nm The retention time for Imeglimin hydrochloride was found to be 3.47 min. The developed method was successfully with results falling within acceptable criteria validated for different validation parameters as per (ICH-Q2 (R1)) guidelines. The linear regression equation was found to be y = 27.83x - 8.512 with a correlation coefficient (R2) > 0.999 which shows excellent linear correlation. Accuracy, precision, specificity, system suitability, robustness, linearity, LOD and LOQ were determined for method validation. The results were found to be well within recommended limits as per ICH guidelines. Stability studies of Imeglimin hydrochloride were carried out under acidic, basic, peroxide, photolytic and thermal conditions. Degradation was observed in acidic, basic, and oxidative conditions, but not in photolytic and thermal conditions.  

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bempedoic acid and Ezetimibe in bulk and tablet dosage form.(1) Chromatogram was run through Kromosil C18 150 x 4.6 mm, 3.0m. Mobile phase containing 0.01N Kh2Po4 Buffer: Methanol taken in the ratio 70:30 was pumped through the column at a flow rate of 0.9ml/min. The buffer used in this method was 0.01N Kh2Po4 buffer. Temperature was maintained at 30°C. The optimized wavelength selected was 260.0 nm. The retention time of Bempedoic acid and Ezetimibe was found to be 2.780min and 2.123min. %RSD of the Bempedoic acid and Ezetimibe were found to be 0.6 and 1.3 respectively. % Recovery was obtained as 99.87% and 100.12% for Bempedoic acid and Ezetimibe respectively. LOQ, and LOD values obtained from regression equations of Bempedoic acid and Ezetimibe were 0.10, 0.35, and 0.01, 0.03 respectively. The regression equation of Bempedoic acid is y = 28262x + 4418.6, and y = 28796x + 190.13 of Ezetimibe. Retention times were decreased and that run time was decreased, so the method developed was simple and economical and can be adopted in regular Quality control tests in Industries.       

A simple, Accurate, precise method was developed for the simultaneous estimation of the Rilpivirine and Cabotegravir in dosage form. Chromatogram was run through AgilentC18 150 x 4.6mm, 5.0mm.1 Mobile phase containing Buffer 0.1% Ammonium Acetate: Acetonitrile taken in the ratio 55:45v/v was pumped through the column at a flow rate of 1.0 ml/min. Temperature was maintained at 30°C. The optimized wavelength selected was 260 nm. The retention time of Rilpivirine and Cabotegravir was found to be 2.238 min and 2.953 min. %RSD of the Rilpivirine and Cabotegravir was found to be 0.5 and 0.5 respectively. %Recovery was obtained as 99.85% and 99.84% for Rilpivirine and Cabotegravir respectively. LOD and LOQ values obtained from regression equations of Rilpivirine and Cabotegravir were 0.11, 0.3,2, and 0.02, 0.06 respectively.2 The regression equation of Rilpivirine is y = 17712x + 2324.3 and y = 17293x + 1410.5 of Cabotegravir Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.  

A simple, precise, and accurate method was developed for the simultaneous estimation of Nivolumab (NVM) and Cabozantinib (CBZ) in tablet dosage form.  The chromatogram was analyzed through a Phenomenex C18 150 mm (4.6 x 150 mm, 5 m) for chromatogram processing. A mobile phase containing formic acid: methanol (50:50) was pumped through the column at a spurge flow of 1.0 mL/min.  The column temperature was upheld at 30°C.  The quantification was done at 260.0 nm.  The elution time of NVM and CBZ was found to be 2.243 min and 2.953 min, respectively. The validation for the developed method was performed and all the parameters were found within the specified limits. The standard curve results represent a correlation coefficient of more than 0.999.  The %RSD of NVM and CBZ were found to be 0.9 and 0.7, respectively.  % Recovery was achieved as 99.88% and 99.66% for NVB and CBZ, respectively. The NVM and CBZ regression equations yielded LOD and LOQ values of 0.63, 1.91, and 0.08, 0.24 respectively. The equation of Nivolumab y is 39306x + 12173 while the Cabozantinib y is 34894x + 1139.7. With all the parameters under the criteria, the developed method for the simultaneous estimation of Nivolumab and Cabozantinib can be successfully applied for regular quality control approaches.

A straightforward and accurate method was devised for simultaneously determining Drospirenone and Estetrol in tablet dosage form. The chromatogram was generated using a Kromosil C18 column (150 x 4.6 mm, 5.0 mm), with a mobile phase consisting of Buffer 0.01N KH2PO4: Methanol in an 80:20 ratio, flowing through the column at a rate of 1.0 ml/min. This method utilized OPA as the buffer, and the temperature was maintained at 30°C. The optimized wavelength for detection was set at 263.0 nm. The retention times for Drospirenone and Estetrol were determined to be 2.597 min and 2.1336 min, respectively, with %RSD values of 0.4 for both compounds. The %Recovery was calculated as 100.25% for Drospirenone and 100.09% for Estetrol. The LOD and LOQ values were obtained from the regression equations of Drospirenone and Estetrol, resulting in 0.01 and 0.02 for LOD, and 0.08 and 0.25 for LOQ, respectively. The regression equations for Drospirenone were found to be y = 361228x + 6065.6, and for Estetrol, y = 341114x + 46689. The method exhibited reduced retention times and overall run time, indicating its simplicity and cost-effectiveness. This makes it suitable for routine quality control testing in various industries.

We developed a straightforward, precise method for the simultaneous estimation of Ivacaftor, Elexacaftor and Tezacaftor in both bulk and tablet dosage forms. The chromatography analysis was performed using a Discovery C18 column measuring 150 x 4.6 mm with a 5µm particle size. The mobile phase, composed of Acetonitrile: Methanol: 0.1% OPA (10:35:55 v/v) was pumped at a flow rate of 0.9 ml/min, with the temperature maintained at 28°C. The optimized wavelength for detecting 3 drugs was set at 278.0 nm. Retention times were measured at 2.537 min, 2.089 min, and 3.090 min, respectively. The method precision showed low %RSD values, with 0.4 for Ivacaftor, 0.3 for Elexacaftor and 0.4 for Tezacaftor. Recovery percentages were determined as 99.79% for Ivacaftor, 99.72% for Elexacaftor and 100.05% for Tezacaftor. Furthermore, the LOD and LOQ values derived from the regression equations for  Ivacaftor, Elexacaftor and Tezacaftor i.e  y = 22674x + 2799.3, y = 21285x + 4513.2 and y = 21548x + 869.63  were found to be 0.06 ppm and 0.22 ppm, 0.18 ppm and 0.19 ppm , 0.07 ppm and 0.57 ppm  respectively. With reduced retention times, this method offers simplicity and cost-effectiveness, making it suitable for routine quality control testing.

The purpose of this research is to develop and validate a precise method for UV-Vis spectrophotometric and Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) for determination of Octenidine dihydrochloride in bulk and pharmaceutical preparation. According to the relevant experiment the maximum wavelength was found to be 285nm and it is used for further process of development of method and its validation. The developed methods used for quantitative estimation of Octenidine dihydrochloride in pharmaceutical preparation and bulk drug which shows the satisfactory results as per ICH guidelines, so these developed and validated methods are found very simple, sensitive and rapid according to the ICH guideline and can be successfully applied to estimate the ODCL in bulk and pharmaceutical dosage form.