Abstract

DEVELOPMENT AND VALIDATION OF UV- SPECTROSCOPY BASED STABILITY INDICATING METHOD FOR SIMULTANEOUS ESTIMATION OF RISEDRONATE SODIUM AND URSOLIC ACID.

Niha Sultana, Asad Ali, Ayesha Waheed, Mohd Aqil*, Yasmin Sultana, Mohd Mujeeb, and Abdul Qadir

Abstract

Formulation of a pharmaceutical product with dual or combined drug delivery system gives a challenge for simultaneous determination and identification of the both the drugs. Among various methods available, UV spectroscopy happen to be the most simple, accurate and reliable method. We have successfully developed and validated the UVSpectroscopy method for the simultaneous estimation of the Risedronate Sodium and Ursolic Acid. The percentage recovery of each drug from the developed simultaneous equation was found to be 98.6% and 99.9% for RIS and UA respectively. The method was validated for accuracy and precision. The average percent recovery of RIS was found to be 99.06%, whereas for UA it was found to be 98.83%. Percent RSD in intra-day analysis was found to be 0.45288% and 0.4587% for RIS and UA respectively. Similarly, Percent RSD in inter-day analysis was found to be 0.89092% and 0.9096% for RIS and UA respectively. From the obtained results we infer that our method is accurate and precise. We have further validated our method by applying on stability study done via forced degradation testing. We have observed that in acidic, alkali and oxidative degradation conditions, both of our drugs were degraded. Photolytic and thermal degradation tests were also performed. From the results it was observed that our simultaneous estimation UVSpectroscopy method is reliable and can pave the way for future investigations.

Keywords: forced degradation study, risedronate sodium, simultaneous estimation, stability study, ursolic acid, uv spectroscopy.