Abstract

Validation of a Newly Developed Stability Indicating RP-Liquid Chromatographic Method for the Quantitative Determination of Dapagliflozin

Author(s): Sreenivasulu Sura, Rameswara Rao Modalavalasa, ChandraSekhar B Kothapalli

A novel simple, user friendly and stability representing high performance liquid chromatographic method for estimation of dapagliflozin in API and pharmaceutical forms was developed and validated. A Phenomenex Gemini-NX C18 Column (250 mm length, 4.6 mm diameter, 5 μm particle size) with a mobile phase containing of Methanol: Sodium 1-octanesulphonate in the proportion of 70:30 v/v was utilized for the chromatographic elution study. An injection volume of 20 μl with a flow rate of 1.0 ml/min was chosen for this investigation and the created technique was validated with various parameters like: Linearity, Limit of Detection (LOD), Limit of Quantification (LOQ), precision, accuracy, robustness and ruggedness. Dapagliflozin was eluted at 5.5 ± 0.5 min at wavelength 203 nm. The anticipated technique is linear in the range of 10-50 μg/ml and correlation co-effective (r2) got as 0.9994. The theoretical plates and peak tailing was discovered as 4229 and 1.03 respectively. The percentage accuracy in terms of recovery was accomplished in acceptable range of 98-102. The recently proposed, validated technique is distinct and reproducible for the normal investigation of dapagliflozin in bulk form. Proposed method stability was established by forced degradation studies of drug. In this examination the product was degraded under states of acidic hydrolysis and alkaline hydrolysis, oxidation, photolytic and thermal stress in light of the proposals of International Conference on Hormonization (ICH) Q2R1 Guidelines.

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