Background A simple, robust, precise, and an accurate HPLC method was established for simultaneous estimation of xylometazoline hydrochloride and ipratropium bromide from a nasal spray dosage form. The effective separation was obtained by injecting 10 μl of sample and standard solutions on to an Inertsil ODS column, 250 × 4.6, mm, 5 μ at 45 °C using phosphate buffer with 1-pentane sulphonic acid sodium salt at pH 4.7 as a mobile phase A and acetonitrile as the mobile phase B. The gradient was optimized with a flow rate of 1 mL/min and a wavelength of 210.0 nm. Result The complete analytical method validation was successfully carried out as per ICH guidelines. The retrieval study was carried out at 50% to 150% level of working concentration, and results were in the range of 99 to 101% for both the analytes. The linearity was proven from 4 to 150% of working concentration with linear regression curve (R2=0.999) for both the analytes. The developed method was robust for different parameters like column temperature, flow rate, mobile phase pH, composition, and gradient. Conclusion The developed HPLC method can be successfully used for the estimation of xylometazoline hydrochloride and ipratropium bromide from nasal spray dosage form as a release test in QC department of manufacturing units.
Design and development of analytical methods with environment friendly reagents and solvents is the need of the hour for labs engaged in analytical services. Every year thousands of chemical and pharmaceutical laboratories worldwide are generating tons of toxic chemical wastage causing environmental pollution thereby endangering the human existence. The objective of this study was to develop and validate a sensitive, stability-indicating, accurate and precise green chemistry RP-HPLC method with RI detector for the simultaneous quantitation of glucosamine and chondroitin sulfate from various pharmaceutical dosage forms. Complete separation of both the actives was achieved in isocratic mode by using Hypersil BDS Phenyl (250 x 4.6 mm, 5µm) HPLC column. Purified water as a diluent and phosphoric acid buffer pH 2.5 was used as a mobile phase at a flow rate of 0.2 mL/min. The column temperature was maintained at 40°C. Both the molecules being non-chromophoric in nature, refractive index (RI) detector was used for detection. The proposed method being environment friendly does not require organic solvents, gradient elution and complex derivatization unlike the reported methods. The developed method is successfully validated as per ICH guidelines. The method is stability indicating, sensitive and economical. Hence, it can be successfully used for the routine analysis of commercial batches of these combination products.
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