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A simple, precise, rapid and accurate RP-HPLC-PDA method has been developed for the simultaneous estimation of drotaverine HCl (DRT) and aceclofenac (ACE) in combined tablet dosage form. Formulation containing DRT with ACE are used as antispasmodic and anti-inflammatory agent. The chromatographic separation was achieved on Qualisil BDS C8 column (250 mm x 4.6 mm, 5.0 μ particle size) using methanol: THF: acetate buffer (68:12:20 v/v) pH adjusted to 5.0 with acetic acid, flow rate was 1.0 mL min-1 and column was maintained at 50 0C. Quantification and linearity was achieved at 298 nm over the concentration range of 1 - 150 μg mL-1 for Drotaverine HCl and 1.25 – 187.5 μg mL-1 for Aceclofenac. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines.
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