The study established and afterwards validated an “stability indicating RP–HPLC” stratagem for assessing lamivudine (LAD), doravirine (DOR), & tenofovir (TED). RP-HPLC separation & assessment of LAD, DOR & TED was accomplished with a mobile phase of KH2PO4 (0.1M concentration, 5.2 units pH) plus methanol solvent solutions at a 65:35 v/v percentage and 1 ml/min flow stream. The detector arranged at 237 nm. Elution times for LAD is 2.531 min, DOR is 5.691 min & TED is 3.530 min. The “stability indicating RP–HPLC” stratagem was proved quantity varied from 150 to 450 μg/ml for LAD, from 50 to 150 μg/ml for DOR & from 150 to 450 μg/ml for TED. Acceptable assessments were documented in precision study (RSD% - 0.230% for LAD; RSD% - 0.187% for TED; & %RSD – 0.264% for DOR) and accuracy study (recovery % - 98.98% for LAD; recovery% - 99.16% for TED; & recovery% – 98.53% for DOR). Robustness of “stability indicating RP–HPLC” stratagem also was discovered to be acceptable. Also, during degradation check, obstruction in the evaluation of the LAD, DOR & TED wasn't really discovered. The created “stability indicating RP–HPLC” stratagem also proved significant in a dissolution assessment of Delstrigo tablets comprising LAD, DOR, & TED as active components in combo.
Two simple and sensitive extractive spectrophotometric methods have been described for the assay of Lansoprazole (LPZ) either in pure form or in pharmaceutical formulations. The methods were based on the formation of ion-pair complex between LPZ and Metanil Yellow (MY) -Method-A and methyl orange (MO)-Method-B, at pH 2.5 has been described. The formed complex were extracted quantitatively into chloroform and measured at 440 nm and 450 nm with MY and MO respectively. Beer's law was obeyed in the concentration range of 20-70 µg mL -1 and 6-16 µg mL -1 with molar absorptivity of 1.329 x 10 -8 and 1.822 x 10 -8 L mol -1 cm -1 with MY and MO respectively. Statistical comparison of the results of the proposed method with those of the reference method shows excellent agreement and indicates no significant difference in accuracy and precision. The limits of detection and quantification have been determined for two methods. Both the methods have been validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial capsules and results of analysis were validated statistically through recovery studies
A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Atogepant bulk and pharmaceutical formulations. Separation of Atogepant was successfully achieve Dona: WATERS 150X4.6mm, 5µm, C18 or equivalent in an isocratic mode utilizing K2HPO4: Methanol (55:45) at a flow rate of 1.0 mL/min and eluate was monitored at 272nm, with a retention time of 2.860 minutes for Atogepant respectively. The method was validated and their response was found to be linear in the drug concentration range of 50µg/ml to150 µg/ml for Atogepant. The values of the correlation coefficient were found to 1.000 for Atogepant respectively. The LOD and LOQ for Atogepant were found to be 0.050 and 0.165 respectively. This method was found to be good percentage recovery for Atogepant were found to be 100 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analyte in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Accuracy, Precision, Specificity and Robustness.
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