Complex GenericsA complex generic product is a medicine that can be prescribed as a substitute for the originator specialized product because the bioequivalence has been demonstrated; however it is not as simple as generics to get manufactured. To be "complex generic", a medicinal product must preliminarily exhibit not

& A novel stability-indicating reversed phase liquid chromatographic (RP-LC) method was developed for the determination of purity of Nizatidine in Nizatidine oral solutions in the presence of its impurities and degradation products. Two unknown impurities were formed in the formulated drug under the stress conditions (40 C=75% RH for 3 months), with relative retention times (RRTs) 0.93 and 2.14. The two degradant impurities were isolated and characterized using liquid chromatography mass spectrometry (LC-MS). Chromatographic method was developed and validated for Nizatidine United States Pharmacopeia (USP) impurities along with the two degradant impurities. Total 13 impurities were well separated and not interfering with placebo peaks in oral solution. The method was developed using C-18 column in gradient elution mode. The eluted compounds were monitored at 254 nm. Nizatidine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness, and ruggedness.

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