A Novel Validated GC-MS/MS Method for the Estimation of N-Nitroso Dimethyl Amine and N-Nitroso Diethyl Amine in Zidovudine.

A novel method has been developed for the estimation of N-Nitroso dimethyl amine impurities (NDMA) and N-Nitroso diethyl amine (NDEA) in Zidovudine by using Gas chromatograph Triple Quadrupole Mass with Liquid autosampler (GC-MS/MS) and the method is validated as per International Conference on Harmonization recommendations. Sample analysis was executed for Zidovudine by developed method. Both NDMA and NDEA were detected in below quantitation limit for the Zidovudine batches.

A validated stability-indicative UPLC method for nilotinib hydrochloride for the determination of process-related and degradation impurities.

A novel stability-indicating ultra performance liquid chromatographic (UPLC) method has been developed for quantitative determination of nilotinib hydrochloride in active pharmaceutical ingredients along with four impurities (imp-1, imp-2, imp-3 and imp-4). The method is applicable to the quantification of related compounds and assay of nilotinib hydrochloride drug. Efficient chromatographic separation was achieved on a Shim-pack XR-ODS II, 75 × 3.

Stability-indicating HPLC method for determination of fosamprenavir calcium.

A novel stability-indicating reverse-phase high-performance liquid chromatographic (HPLC) method has been developed for quantitative determination of Fosamprenavir Calcium, HIV-1 protease inhibitor. Chromatographic separation was achieved using an YMC Pack ODS AQ (150 mm × 4.6 mm × 3.

A validated stability-indicating UPLC method for the determination of impurities in Maraviroc.

Maraviroc is an antiretroviral drug in the CCR5 receptor antagonist class, which is used in the treatment of HIV. Maraviroc has six impurities. A novel, stability-indicating reversed-phase ultra-performance liquid chromatography (RP-UPLC) method has been developed for the quantitative determination of maraviroc in active pharmaceutical ingredients, along with its six impurities.