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A simple, sensitive and specific liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed for the quantification of milnacipran (MC) in rat plasma by using the liquid–liquid extraction method. Milnacipran-d10 (MCD10) was used as an internal standard (IS). Chromatographic separation was achieved on Zorbax SB-CN (4.6 mm×75 mm, 3.5 µm) column with an isocratic mobile phase composed of 10 mM ammonium acetate (pH 4.0) and methanol in the ratio of 25:75(v/v), at a flow-rate of 0.7 mL/min. MC and MCD10 were detected with proton adducts at m/z 247.2→230.3 and m/z 257.2→240.4 in multiple reaction monitoring (MRM) positive mode respectively. The method was validated over a linear concentration range of 1.00–400.00 ng/mL with a correlation coefficient (r2)≥0.9850. This method demonstrated intra- and inter-day precision within 5.40–10.85% and 4.40–8.29% and accuracy within 97.00–104.20% and 101.64–106.23%. MC was found to be stable throughout three freeze–thaw cycles, bench top and postoperative stability studies. This method was successfully applied to a pharmacokinetic study of rats through i.v. administration.

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ICH-international council for harmonization of technical requirements for pharmaceuticals for human use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH mission is to achieve greater harmonization worldwide to ensure that safe, effective and high quality medicines are developed and registered in the most resource -efficient manner. Harmonization achievements in quality area include pivotal milestone such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more manufacturing practice (GMP) risk management.

Accurately 10 mg of Tigecycline pure drug was weighed and transferred into a 10 ml volumetric flask. The volume was made up to the mark using Acetonitrile (ACN) resulting in 1000 μg/ml concentration primary stock solution. From this 1 ml aliquot was transferred into a 10 ml volumetric

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Rivaroxaban is prescribed to patients with nonvalvular atrial fibrillation to reduce the risk of stroke and blood clots in blood vessels. It is applied to the management of vascular blood clots. Goal: To create a method for estimating the dosage of Rivaroxaban in tablets and bulk using RP-HPLC that is straightforward, specific, accurate, and exact. The C18 column was used to provide the optimal circumstances. Acetonitrile: water (60:40) with pH adjusted to 4 with formic acid. Flow rate maintained at 1.0 ml/min. λmax was detected at 249.5nm. The retention time for Rivaroxaban was found at 2.44min. Linearity was obtained in the range of 10-45μg/ml. Recovery studies were performed and %Recovery was found to be 99.91±0.1.%RSD was found to be within the limits i.e., less than 2. The correlation coefficient from the linearity plot was found to be 0.999. By considering all the results obtained, the method can be successfully applied for estimating Rivaroxaban in bulk and tablet dosage by RP-HPLC without interfering with any of the excipients and commonly used substances.

Aims: To develop and validate a new, simple, rapid, precise and accurate Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the quantitative determination of Tigecycline in bulk and pharmaceutical dosage form. Study Design: Place and Duration of the Study: RBVRR women's college of pharmacy, Barkatpura, Hyderabad, between june 2019 and july 2020. Methodology: The RP-HPLC method was developed on Sunsil C18 150 mm x 4.6mm x 5µ column using acetonitrile : water (pH maintained at 3.5 with acetic acid) [70:30] as mobile phase at flow rate 0.8 ml/min and UV detection at 250 nm. Results: Tigecycline exhibited linearity over the concentration range of 5-40 µg/mL (R2 > 0.999). The analytical method showed good precision with % RSD below 2. The method showed suitable accuracy and robustness. Conclusion: Validation of the developed method was done as per International Conference on Harmonization (ICH) Q2R1 guidelines.