STABILITY INDICATNG HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF AMBROXOL HCL AND LORATADINE

pharmacy

The objective of present work was to develop a simple, accurate, rapid and precise Stability Indicating UV- Spectrophotometric method for simultaneous estimation of Ambroxol hydrochloride (AMB) and Loratadine (LORA) in bulk and tablet Pharmaceutical dosage form using Area Under Curve (AUC) method. It involves measurement of area under curve in the range of 310-320 nm for AMB and 240-250 nm for LORA in methanol. The linearity was observed in the concentration range of 12-72µg/ml for AMB and 1-6µg/ml for LORA with a correlation coefficient (r2) of 0.999 for AMB and 0.998 for LORA respectively. Assay results of marketed formulation were found to be 98.85% for AMB and 100.11% for LORA. Satisfactory values of percent recovery indicated accuracy of the method. The value of % RSD for Intra-day and Inter-day precision were found to be 1.1718 and 0.2018 for AMB and 0.6159 and 1.3696 for LORA respectively. Limit of Detection and Quantitation was found to be 0.2207µg/ml and 0.6688µg/ml for AMB and 0.6648µg/ml and 1.6548µg/ml for LORA respectively. The proposed method was successfully applied for quantitative detection of AMB and LORA in pharmaceutical dosage form. The method was validated according to ICH guidelines.

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