Original Article ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF FLAVOXATE HCL WITH RP- HPLC AAKRITI BHARDWAJ 1 , ROBIN KUMAR 2 , SHABNAM AIN 1* , BABITA KUMAR 1 , QURRATUL AIN 1 1 Sanskar College of Pharmacy and Research, Ghaziabad-201001, Uttar Pradesh, India. 2 Principle Scientific Officer, IPC, Ghaziabad-201001, Uttar Pradesh, India * Corresponding author: Shabnam Ain; * Email: shabnam.ain@sanskar.org Received: 16 Oct 2024, Revised and Accepted: 12 Feb 2025 ABSTRACT Objective: To verify analytical methods, suitability for its intended use is the goal of validation by Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method. Methods: A validated method for determining flavoxate hydrochloride was created using HPLC, which is a sensitive, exact, and straightforward technique. The inertsilC18 (150 mm×4.6 mm, 5μm) is used in this approach. The buffer, which included 3g of 1-hexane sulphonic acid, 3 ml of Orthophosphoric Acid (OPA) and 3 ml of Triethylamine (TMA), was combined with Acetonitrile (ACN) in a 650:350 ratio to form the mobile phase. At 293 nm, Ultraviolet (UV) detection was done. Results: The Retaining time for flavoxate HCl was found to be 2.43 min. It was discovered that the linearity range of flavoxate HCl was 800-1200 μg/ml, and that the regression equation was y=17118x+80943. R 2 = 0.981 was found to be the linearity regression coefficient value. It was discovered that the RSD for intra-and inter-day precision was less than 2 %. Flavoxate HCl was discovered to have Limit of Detection (LOD)-83.13734 and Limit of Quantitation (LOQ)-251.9313 values of μg/ml and μg/ml, respectively. After statistical analysis, the results are deemed satisfactory. Conclusion: This technique can be used to analyze bulk forms of the antimuscarinic medication flavoxate HCl with success. Keywords: Accuracy, Flavoxate HCl, HPLC, Precision, Validation © 2025 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/) DOI: https://dx.doi.org/10.22159/ijpps.2025v17i4.53045 Journal homepage: https://innovareacademics.in/journals/index.php/ijpps INTRODUCTION Pharmaceutics is a subspecialty of pharmacy that studies how drugs are made into dosage forms. It is a methodical process to obtain a stable and effective formulation while taking into account all factors necessary to preserve its quality. The development, formulation, production, testing, and distribution of medication dosage forms are within the multidisciplinary field of pharmaceutics in pharmaceutical research. Physical pharmacy, pharmaceutical technology, biopharmaceutics, pharmacokinetics, and pharmaceutical analysis are only a few of the many topics it covers. For quality assurance and control throughout the medication research and production process, this field is essential [1-3]. Overactive Bladder (OAB) is a label for a group of urinary symptoms. The need to urinate might come on suddenly and be difficult to control. You may feel the need to urinate often during the day and night. Urgency incontinence refers to the unintentional loss of pee. Those who suffer from an OAB may experience feelings of insecurity. Fortunately, there is a treatment available, an artificial anticholinergic and antispasmodic drug called flavoxate HCl is used to treat OAB syndrome and urine problems. It is used to treat problems related to the bladder, including incontinence (leaking urine), painful urination, frequent or urgent urination, increased urination at night, and so on. Bladder infections, urethral irritation, enlargement of the prostate and OAB are the most common causes of these symptoms. Although flavoxate has a broad range of activity against muscarinic acetylcholine receptors, it is thought to have less ability to affect the central nervous system due to its highly polar quaternary ammonium group, which makes it less likely to pass lipid membranes like the Blood Brain Barrier (BBB) [4, 5]. Urine frequency and urgency are reduced and bladder capacity is increased by flavoxate. Since its approval for usage in 1970, flavoxate has been used in the US to treat OAB syndrome and cystitis symptoms [6, 7]. Flavoxate was once marketed under the brand name Uri spas and is available in 100 mg tablets in a number of generic variants. Parasympathetic stimulation frequently causes adverse symptoms such as dry mouth and eyes, headache, blurred vision, constipation, urine retention, impotence, tachycardia and palpitations, anxiety, restlessness, and in rare cases, agitation and delusions [8]. The ingredient "flavoxate hydrochloride" in flavoxate HCl relaxes the muscles in the bladder. As a result, it aids in the prevention of excessive or uncontrollably frequent urination. Drug use observation research included 1800 patients who received flavoxate (Spasuret®200) for urge incontinence over a two-week period. Parameters for effectiveness and tolerance were established. Flavoxate alone was used to treat a subset of 618 patients who did not have benign prostatic hyperplasia or urinary tract infections. Comparable to results from the full sample (1800 patients), the bladder capacity increased by 36% at the onset of urge sensation. The remaining urine volume was either steady or decreased in 89.2% of all individuals. In 1.8% of cases, undesirable side effects were experienced. When flavoxate was taken four times a day (800 mg) as opposed to three times a day (600 mg), both groups performed better. Flavoxate works effectively, is well tolerated, and has no negative side effects or leftover urine issues [9]. Modern pharmaceutical and biological analyses rely on High- Performance Liquid Chromatography (HPLC) as their primary separation method because to its very successful separations and generally high detection sensitivity. HPLC technique development and validation are critical to research, manufacturing, and drug discovery, among other applications [10-12]. Every facet of validation-related performance characteristic is covered in the International Conference on Harmonization (ICH) Guidelines for HPLC method validation. These include testing for system appropriateness, linearity, specificity, accuracy, precision, range and limit of finding, and limit of detection [13-15]. In the absence of established ways, methods are created for new products. A different approach to improve precision and durability for current (non-pharmacopoeia) products is to cut costs and International Journal of Pharmacy and Pharmaceutical Sciences Print ISSN: 2656-0097 | Online ISSN: 0975-1491 Vol 17, Issue 4, 2025