Chronopharmacokinetics of BD were achieved with the help of Eudragit coatings on pellets. The BMP and BMPP formulations were found to be reasonably stable over a period of time. Thus, optimal chronopharmacokinetics of BD was achieved successfully by multiparticulate pulsatile technology.

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A new liquid chromatography with tandem mass spectrometry systematic procedure was envisaged for determination of l‐menthol glyoxylate and (1R,2S,5R)‐menthyl‐5(R,S)‐acetoxy‐(1,3)‐oxathiolane‐2(R)‐carboxylate, the potential genotoxic impurities in lamivudine salicylate drug formulation. The process describes an effective use of Hypersil BDS C8 (50 mm × 4.6 mm, 3.0 µm) column retained at 40°C and positive ion electrospray ionization in multiple reaction‐monitoring mode for quantification of two genotoxic impurities. The mobile phase comprises of 60:40 ratio of 5 mM ammonium formate and combination of acetonitrile/methanol (50:50 v/v) pumped at the flow rate of 0.5 mL/min with run time 10 min. This approach was validated for robustness, reproducibility, precision, linearity, accuracy, limit of detection and limit of quantification by following ICH guidelines. The established approach is able to assess two genotoxic impurities at 0.3 ppm (LOQ) against to 2.0 mg/mL of lamivudine. The linearity of this approach is found to 0.3–10.0 ppm, which meets the quantified accepted level (5.0 ppm) in LOQ‐200% range with the correlation coefficients of 0.999 and 0.997. Accuracy was arrived between 98.7–103.1%. The validated method could be highly useful as a good quality assessment tool for quantitation of genotoxic impurities in lamivudine formulation.

DOI: http://doi.org/10.1002/sscp.201900032 The cover picture shows the schematic pictorial representation of lamivudine salicylate stepwise for the development and validation for genotoxic impurities. A new LC‐MS/MS method developed and validated for the quantification of l‐menthol glyoxylate and (1R,2S,5R)‐menthyl‐5(R,S)‐acetoxy‐(1,3)‐oxathiolane‐2(R)‐carboxylate genotoxic impurities present in lamivudine salicylate. The genotoxic impuritieswere quantified up to trace level concentration of 0.3 ppm (LOQ) in short run time. The method is highly recommended for regular routine analysis for samples in production stage and to test the stability of lamivudine salicylatedrug dosage.