A simple, accurate, precise, economical and cost-effective UV Spectrophotometric method has been developed for simultaneous estimation of Ketoprofen and Thiocolchicoside in solid oral dosage form and validated as per International Conference of Harmonisation guidelines. Estimation of Ketoprofen and Thiocolchicoside was conducted by using simultaneous equation method based on measurement of absorbance at two wavelengths. The solvent used was methanol and the λmax of Ketoprofen and Thiocolchicoside were found to be 251.5 nm and 372 nm respectively. At 251.5 nm both the drugs have considerable absorbance. The linearity was found in the range of 5-25 μg/ml and 4-20 μg/ml for Ketoprofen and Thiocolchicoside respectively. The linearity coefficient was found to be 0.995 at 251.5 nm for Ketoprofen and 0.986 and 0.996 at 251.5 nm and 372 nm for Thiocolchicoside respectively. Recovery study values of Ketoprofen and Thiocolchicoside was found to be 99.84% and 100.57% respectively. % RSD for intra-day and inter-day precision studies was found to be less than ± 2. The Limit of Detection and Limit of Quantitation were found to be 16.58 μg/ml and 50.25 μg/ml for Ketoprofen and 13.25 μg/ml and 40.16 μg/ml for Thiocolchicoside respectively. The proposed method was satisfactorily validated as per the ICH guidelines and can be successfully employed for routine analysis of Ketoprofen and Thiocolchicoside in solid oral dosage form.
This paper describes validated reverse phase high-performance liquid chromatographic (RP-HPLC) method for simultaneous estimation of trihexyphenidyl hydrochloride (THP) and risperidone (RSP) in the pure powder form and in combined tablet dosage form. The HPLC separation was achieved on a core shell C18 (100 mm length × 4.6 mm, 2.6 m particle size) using methanol : ammonium acetate buffer 1% (85 : 15 v/v; pH-6.5) as mobile phase and delivered at flow rate of 0.8 mL/min. The calibration plot showed good linear relationship with r 2 = 0.997 ± 0.001 for THP and r 2 = 0.998 ± 0.001 for RSP in concentration range of 50-175 g/mL and 50-175 g/mL, respectively. LOD and LOQ were found to be 0.40 and 1.29 g/mL for THP and 1.24 and 3.92 g/mL for RSP. Assay of THP and RSP was found to be 100.16 ± 0.03% and 99.83 ± 0.02%, respectively. THP and RSP were subjected to different stress conditions (acidic, basic, oxidative, thermal, and photolytic degradation). The degraded product peaks were well resolved from the pure drug peak. The method was successfully validated as per the ICH guidelines. The developed RP-HPLC method was successfully applied for the estimation of THP and RSP in tablet dosage form.
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