stability-indicating

A rapid stability-indicating RP-HPLC was developed and validated for the estimation of Mirabegron and Solifenacin combination in bulk and tablet dosage form using Thermo C18 column (250 x 4.6 mm, 5m) as a stationary phase and a mixture solution of 0.1 percent Diazanium sulphate buffer: Acetonitrile (60:40 v/v) as the mobile phase at a flow rate of 1 ml/min. A photodiode array detector was used for detection at 246 nm. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were all determined. The peak area response-concentration curve was rectilinear over the concentration ranges of 25-75 g/ml (Mirabegron) and 2.5-7.5 g/ml (Solifenacin), with quantitation limits of 0.793 g/ml (Mirabegron) and 0.307 g/ml (Solifenacin). The proposed method was validated for the simultaneous determination of mifepristone and misoprostol in combined tablet dosage form. In comparison to previously reported RP-HPLC methods, the performance of the proposed method was found to be rapid and cost-effective. The developed and validated stability-indicating RP-HPLC method was suitable for quality control and drug analysis.

A simple, specific, accurate and stability-indicating reversed phase High Performance Liquid Chromatographic method was developed for the simultaneous determination of Clindamycin Phosphate and Benzoyl Peroxide, using a C18 column and a mobile phase composed of 20 mM Ammonium acetate buffer pH 4.0: Methanol (45: 55 %v/v) as mobile phase at flow rate of 1.2 ml/min with detection wavelength of 210nm. Retention times in RP-HPLC method were found to be 4.49 min, 8.78 min for Clindamycin Phosphate and Benzoyl Peroxide, respectively. Linearity of Clindamycin Phosphate and Benzoyl Peroxide were found in the range of 10.0-30.0 µg/ml and 25.0-75.1 µg/ml. The % recovery of Clindamycin Phosphate was found to be 98.45- 101.0 and 99.8- 99.38 for Benzoyl Peroxide. Both the drugs were subjected to acid, alkali, oxidation, thermal and sunlight degradation. The degradation products of Clindamycin Phosphate and Benzoyl Peroxide were well resolved from the pure drugs with significant differences in the retention time values. This method can be successfully employed for simultaneous quantitative analysis of Clindamycin Phosphate and Benzoyl Peroxide in gel formulation. The literature survey reveals that currently there is no stability indicating method has been reported for combination of Clindamycin Phosphate and Benzoyl Peroxide till date, Which can be applicable for routine analysis of combined formulation of drugs in quality control laboratories.

A rapid and stability indicating ion-pair reversed phase high performance liquid chromatographic method was developed for qualitative and quantitative estimation of three oxicam drugs: tenoxicam, meloxicam and lornoxicam. The method was validated according to ICH, FDA and USP guidelines with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity and system suitability. The method was developed by using an isocratic condition of mobile phase comprising buffer pH 6.5 [tetra butyl ammonium hydroxide (0.008M) and sodium 1-heptane sulfonate (0.003M)] and acetonitrile in a ratio of 65:35 v/v ratio at a flow rate of 1.5 mL/min over C-18 (ODS, 250 x 4.6 mm) column at ambient temperature. The method showed linear response with correlation coefficient (r2) value of 0.999. The recoveries for all drugs were found more than 99% which demonstrated the accuracy of this method. Intraday and inter-day precision studies of the new method were less than the maximum allowable limit (RSD%£ 2.0). Forced degradation studies were carried on to check its stability indicating property. All the drugs gave sharp peaks within 7min with excellent symmetry and high resolution. Therefore, a rapid, sensitive and stability indicating ion pair RP-HPLC  method was developed for simultaneous separation of tenoxicam, meloxicam and lornoxicam in their any combination or in bulk raw materials.

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of thiocolchicoside  and lornoxicam, using a RP-18 column and a mobile phase composed of 10mM ammonium acetate : methanol(50:50), pH7 adjusted with 1%triethyl amine. The retention time of thiocolchicoside and lornoxicam were found to be 4.6 and 10.2 min, respectively. Linearity was established for both thiocolchicoside and lornoxicam in the range of 1-10 µg/ml. The percentage recoveries of thiocolchicoside and lornoxicam were found to be 100.45±0.4489 and 100.70±0.5111, respectively. Both the drugs were subjected to acid, alkali and neutral hydrolysis, oxidation, dry heat, and photolytic degradation. The degradation studies indicated thiocolchicoside to be susceptible to acid, alkaline and neutral hydrolysis while lornoxicam showed degradation under acid and alkali. The degradation products of thiocolchicoside and lornoxicam were well resolved from the pure drugs with significant differences in the retention time values. This method can be successfully employed for simultaneous quantitative analysis of thiocolchicoside and lornoxicam in bulk drugs and formulations.