DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF ACECLOFENAC AND THIOCOLCHICOSIDE IN PHARMACEUTICAL DOSAGE FORMS

Author

Anuj, Dr. Narendra Singh, Dr. Praveen Goyal

Abstract

 A simple, rapid, accurate, precise, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous determination of aceclofenac (AC) and thiocolchicoside (TH) in pharmaceutical formulations. Chromatographic separation was achieved on an Agilent Zorbax C18 column (150 × 4.6 mm, 5 µm) maintained at 30 ± 1 oC using an isocratic mobile phase consisting of methanol and 0.1% orthophosphoric acid (75:25, v/v) delivered at a flow rate of 1 mL/min. UV detection was monitored at 252nm with an injection volume of 20 µL and a total run time 08 minutes.

The method demonstrated high resolution (Rs =12.19) with sharp, symmetrical peaks (tailing factors 1.05 for AC and 1.12 for TH). Linearity was established across 10 to 100 μg /mL for aceclofenac (r2 > 0.999, Y = 41,278x - 16756) and 5 to 50 μg /mL for thiocolchicoside (r2 > 0.999, Y = 33,680x + 60,388). Mean recoveries ranged between 98.90-100.20% for AC and 99.16-100.56% for TH, fulfilling ICH recovery criteria (98–102%). Precision studies exhibited relative standard deviations (%RSD) well below 2% (0.15% for AC and 0.08% for TH). Limits of detection (LOD) and quantification (LOQ) confirmed high sensitivity suitable for routine quality control and regulatory release testing.

Keywords

Aceclofenac, Thiocolchicoside, RP-HPLC, Method Validation, ICH Q2(R1), Simultaneous Estimation.

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