A stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of orbifloxacin in tablet dosage forms. Reversed-phase chromatography was performed on a Symmetry Shield RP-18 Waters ® , 250mm 4.6mm i.d., 5 m particle size column with 5% acetic acid:methanol (80:20, v/v) as mobile phase at a flow rate of 0.7 ml/min. PDA detection was performed at 290 nm. A well resolved peak was obtained for orbifloxacin at a retention time of approximately 7.9 min. For stress studies the drug was subjected to oxidation, hydrolysis, photolysis and thermal degradation. The developed method was validated as per ICH guidelines for the parameters such as system suitability, linearity, limit of quantification (LOQ), limit of detection (LOD), precision, accuracy, selectivity and robustness. Results obtained were found to be satisfactory. No interference from any excipients in the pharmaceutical dosage form or degradation products was observed.

A reverse phase liquid chromatographic analytical method was developed for the simultaneous determination of Dapivirine and DS003 content in tablet dosage form. The chromatographic separation was achieved by using a C 18 column with mobile phase containing a gradient mixture of 0.05% v/v trifluoroacetic acid in water as mobile phase A and acetonitrile as mobile phase B at a flow rate of 0.5 ml/min. Both of the analytes were quantified with a UV detector at 245 nm. Dapivirine and DS003 were subjected to the stress conditions of oxidation, acid and base hydrolysis and thermolysis. The analytes were found to be stable under acidic and thermal conditions. Dapivirine was not significantly affected by base hydrolysis but was severely affected by oxidative conditions. DS003 was significantly affected by both oxidation and base hydrolysis. The stability-indicating capability of this method was demonstrated by adequate separation of the degradation peaks from those of the actives in the stress degraded samples. The method was validated for linearity, specificity, system suitability, precision and accuracy in accordance with ICH guidelines. The proposed method was applied to quantitate Dapivirine and DS003 in drug-excipient compatibility studies, assay of the tablets and stability studies of Dapivirine and DS003 tablets.

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