Development and validation of a stability-indicating RP-HPLC method of cholecalciferol in bulk and pharmaceutical formulations: Analytical quality by design approach

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dc.contributor.authorSuryawanshi, Dilipkumaren_US
dc.contributor.authorJha, Durgesh Kumaren_US
dc.contributor.authorShinde, Umeshen_US
dc.contributor.authorAmin, Purnima D.en_US
dc.date.accessioned2020-10-16T08:56:18Z
dc.date.available2020-10-16T08:56:18Z
dc.date.issued2019-06
dc.description.abstractThe present article utilized analytical quality by design (AQbD) methodology to optimize chromatographic conditionsfor the routine analysis of Cholecalciferol (CHL). Taguchi orthogonal array design and Box–Behnken designwere employed to screen and optimize critical method parameters for augmenting the method performance. Theoptimal chromatographic separation was attained on Eurosphere® 100-5, C8 (250 × 4.6 mm i.d., 5 μm) column in anisocratic elution mode using methanol:acetonitrile (50:50, % v/v) as mobile phase at a flow rate of 1.0 ml/minutesand photodiode array detection at 265 nm. The optimized chromatographic method was successfully validated asper International Council for Harmonisation Q2 (R1) guidelines. The method was found to be linear (r2 = 0.9993)in the range of 20–100 IU/ml. Limit of detection and limit of quantitation were found to be 10 and 20 IU/ml. Theprecision, robustness, and ruggedness values were within the acceptance limits (relative standard deviation < 2). Thepercent recovery of in-house developed 400 IU mouth dissolving tablets and marketed Tayo 60k tablets were foundto be 99.89% and 101.46%, respectively. The forced degradation products were well resolved from the main peaksuggesting the stability-indicating the power of the method. In conclusion, the AQbD-driven method is highly suitablefor analysis of CHL in bulk and pharmaceutical formulationsen_US
dc.identifier.affiliationsDepartment of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, UGC-CAS (Elite Status), Mumbai, India.en_US
dc.identifier.citationSuryawanshi Dilipkumar, Jha Durgesh Kumar, Shinde Umesh, Amin Purnima D.. Development and validation of a stability-indicating RP-HPLC method of cholecalciferol in bulk and pharmaceutical formulations: Analytical quality by design approach. Journal of Applied Pharmaceutical Science. 2019 Jun; 2019 Jun: 021-032en_US
dc.identifier.issn2231-3354
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/210598
dc.languageenen_US
dc.publisherOpen Science Publishers LLPen_US
dc.relation.issuenumber6en_US
dc.relation.volume9en_US
dc.source.urihttps://dx.doi.org//10.7324/JAPS.2019.90604en_US
dc.subjectCholecalciferolen_US
dc.subjectanalytical quality by designen_US
dc.subjectTaguchi orthogonal array designen_US
dc.subjectBox–Behnken designen_US
dc.subjectmethod validationen_US
dc.subjectforced degradation studies.en_US
dc.titleDevelopment and validation of a stability-indicating RP-HPLC method of cholecalciferol in bulk and pharmaceutical formulations: Analytical quality by design approachen_US
dc.typeJournal Articleen_US
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