Stability-indicating HPLC method for the determination of nicardipine in capsules and spiked human plasma. Identification of degradation products using HPLC/MS

Abstract

In this stability-indicating, reversed-phase high-performance liquid chromatographic method for nicardipine (NIC), forced degradation has been employed and the formed degradants were separated on a C18 (150 mm · 3.9 mm, 5 lm) analytical column using a mobile phase consisted of 70% methanol: acetic acid containing 0.01 M triethylamine with pH 4. The flow rate was 1.0 mL/min and the photodiode array detection wavelength was 353 nm. Forced degradation of the drug was carried out under acidic, basic, photolytic, and oxidative stress conditions. Chromatographic peak purity data indicated no co-eluting peaks with the main peaks. This method resulted in the detection of seven degradation products. Among these, two major degradation products from basic hydrolysis, one from oxidation by H 2 O 2 and four from photolytic stress were identified by mass spectral data. A good linear response was achieved over the range of 0.5-40 lg/mL with a limit of detection (LOD) of 0.011 lg/mL and limit of quantification (LOQ) of 0.036 lg/mL. The suggested method was successfully applied for the analysis of NIC in its commercial capsules, with mean% recovery value of 100.11 ± 2.26%. The method was extended to the in vitro determination on NIC in spiked human plasma samples with mean% recovery of 99.04 ± 5.67%. The suggested method was utilized to investigate the kinetics of photolytic induced degradation. ª 2014 The Authors. Production and hosting by Elsevier B.V. on behalf of King Saud University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/3.0/).

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“…HPTLC has higher sensitivity than TLC but less sensitive than HPLC. [32][33][34][35][36][37][38][39][40][41][42] Rufinamide, Roflimilast, Pragabalin, Nizatidine, Naftopidil, Dexamethasone and Moxifloxacin, Levocabastine, AMLO-VAL-HCTZ, Eremantholide C, Silymerin and curcumin, Sofosbuvir and Ledipasvir, n-acetyl cysteine, HPLC -DAD SIM [43][44][45][46][47][48][49][50][51][52][53][54] Diclofenac, Piracetam, Rivaroxaban, Ofloxacine & ornidazole UPLC SIM [55][56][57][58] Isoflavone aglycone in soybean UFLC SIM 59 Desonide HPTLC SIM 60 Loratadine, Clobetasol, TLC SIM [61][62] Nicardipine, Azilsartan medoxomil Pottasium, HPLC-MS SIM [63][64] Ezetimibe, Simavastatin, Zidovudine HPLC-MS/MS SIM [65][66][67] HPTLC has advantages over large no of the sample can apply on a single plate, and the amount of mobile phase required is small, so it has costeffective analysis. HPLC UV method is the most commonly used method for development of stability indicating method, but it has a limit of its detection ability; however it is more sensitive than TLC and HPTLC method.…”