JPTRM Vol. 1 No. 2 (November 2013)

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Browsing JPTRM Vol. 1 No. 2 (November 2013) by Subject "Method Validation"

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    Analytical Method Development and Validation for Assay of Rufinamide Drug
    (Chitkara University Publications, 2013-11) Jitender Singh; Sonia Sangwan; Parul Grover; Lovekesh Mehta; Deepika Kiran; Anju Goyal
    A simple, rapid, sensitive, cost effective, and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the stability testing of rufinamide. The proposed RP-HPLC method was developed on phenome-nex LunaR C-18 5μm,250 mm × 4.6 mm id. Column (at ambient temperature) and a mobile phase consisting of phosphate buffer: acetonitrile (60:40) was delivered at a flow rate of 1.0ml/ min. The analyte was detected by using a UV detector at the wavelength of 293 nm. The method was found to be linear over the concentration range of 50- 150 μgml-1 (r2=0.999). 30. The retention time of rufinamide was 4.717 min.
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    Development and Validation of Static HS-GC Method for the Determination and Quantification of Residual Solvents of Bromhexine Hydrochloride (BHX)
    (Chitkara University Publications, 2013-11) Prafull Mathur; Suvigya Mathur; Anand Kumar Mishra; Tanaji Kunjir
    The determination of residual solvents in drug substances is the mandatory requirement by various health authorities in the world. There are no analytical methods available in the literature that can simultaneously separate and quantitate residual solvents in bromhexine hydrochloride (BHX) active pharmaceutical ingredient (API). This paper describes the development and validation of a simple, efficient, accurate, and robust static headspace gas chromatography method for the determination of residual solvents, namely methanol, ethanol, ethyl acetate, monochlorobenzene, and benzene, in BHXAPI. This new method has been demonstrated to be accurate, linear, precise, reproducible, specific, and robust for its intended purpose. The method gives very good sensitivities viz. detection limits for benzene is 0.4 ppm, ethyl acetate 2 ppm and for others solvents 5 ppm and precision (below 9.0 % RSD) for all solvents. The results of this evaluation strongly indicate that this method can be readily used to determine residual solvents in BHX.