In this stability-indicating, reversed-phase high-performance liquid chromatographic method for flupiritine maleate, forced degradation has been employed and the formed degradants were separated on a C18 column with a 80:20% v/v mixture of methanol-water containing 0.2% (v/v) triethylamine; the pH was adjusted to 3.1. The flow rate was 1 mLmin−1 and the photodiode array detection wavelength was 254 nm. Forced degradation of the drug was carried out under acidic, basic, thermal, photolytic, peroxide, and neutral conditions. Chromatographic peak purity data indicated no co-eluting peaks with the main peaks. This method resulted in the detection of seven degradation products (D1–D7). Among these, three major degradation products from acidic and basic hydrolysis were identified and characterized by 1H-NMR, 13C-NMR, and mass spectral data. The method was validated as per International Conference on Harmonization guidelines (Q2). The linearity of the method was in the concentration range of 20–120 μgmL−1. The relative standard deviations for intra- and interday precision were below 1.5%. The specificity of the method is suitable for the stability-indicating assay.

This work states validated stability indicating HPLC method for estimation of naratriptan hydrochloride. Chromatographic Analysis was performed using LC-GC Qualisil Gold, C18 (250 X 4.6 mm i.d., 5 μ). Isocratic mode of separation was followed. The linearity range of Naratriptan Hydrochloride was 3-18 µg/ml. The value of correlation coefficient was 0.9990. The % RSD values in the Precision studies were < 2%. This confirmed that the method was sufficiently precise. The accuracy of the method was validated by recovery studies and was found to significant and under specification limits, with % recovery 98.56-101.03. The assay result was found to be 100.68%. The method also passes the specifications for robustness parameters. Limit of detection of naratriptan hydrochloride was found to be 0.0173 µg/ml and Limit of quantification of naratriptan hydrochloride was found to be 0.0572 µg/ml and also other ICH guidelines are validated.

Aim: A simple and sensitive analytical method was developed to simultaneously estimate lamivudine (LAM) and dolutegravir (DOL), anti-retroviral drug combination in bulk and dosage forms. Materials and Methods: Separation of analytes was done on a BEH Shield RP18 (2.1 mm × 100 mm × 1.7 mm, 5 μm Particle size) using sodium dihydrogen phosphate pH 4.9 adjusted with orthophosphoric acid: Methanol (60:40, %v/v) as mobile phase pumped at 1.0 ml/min. A photodiode array detector was used to find the detection wavelength at an isosbestic point of 292 nm while maintaining the column temperature at 30°C. With a total run period of 8 min, the mobile phase was utilized as a diluent. The International Council on Harmonization guidelines were followed in the method's validation. The method's capacity to indicate stability was confirmed by experiments on forced degradation. Results: LAM and DOL eluted at 2.88 and 3.83 min, respectively. Both the drugs exhibited excellent linearity between 105.00–315.00 and 17.50–52.50 μg/ml for LAM and DOL, respectively. The LOD and LOQ were found to be 4.51 and 15.03 μg/ml for LAM and 5.82 and 19.41 μg/ml for DOL, respectively, which are very minute concentrations. Conclusion: The method was therefore found to be quite sensitive. The proposed high-performance liquid chromatography technique was thereby sensitive, reproducible, accurate, and reliable for the measurement of LAM and DOL.